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CompletedNCT03354663TactiSenseUpdated Oct 11, 2023Results posted

TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

An interventional study of TactiCath SE in Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.

Read the detailed description

This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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Keywords

  • paroxysmal atrial fibrillation
  • PAF
  • ablation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug
  • Physician's note indicating recurrent self-terminating AF
  • One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure
  • At least 18 years of age
  • Able and willing to comply with all trial requirements
  • Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Exclusion criteria

Exclusion Criteria:

  • Persistent or long-standing persistent atrial fibrillation (AF)
  • Four or more cardioversions in the past 12 months
  • Active systemic infection
  • Known presence of cardiac thrombus
  • Implanted with implantable cardiac defibrillator (ICD)
  • Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
  • Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
  • Left atrial diameter > 5.0 cm
  • Left ventricular ejection fraction \< 35%
  • New York Heart Association (NYHA) class III or IV
  • Previous left atrial surgical or catheter ablation procedure
  • Left atrial surgical procedure or incision with resulting scar
  • Previous tricuspid or mitral valve replacement or repair
  • Heart disease in which corrective surgery is anticipated within 6 months
  • Bleeding diathesis or suspected procoagulant state
  • Contraindication to long term antithromboembolic therapy
  • Presence of any condition that precludes appropriate vascular access
  • Renal failure requiring dialysis
  • Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  • Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Pregnant or nursing
  • Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
  • Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
  • Patient is unlikely to survive the protocol follow up period of 12 months
  • Body mass index > 40 kg/m2
  • Vulnerable subject
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    TactiCath SE

    Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

    Device: TactiCath SE

Interventions

  • DeviceTactiCath SE

    Ablation to achieve pulmonary vein isolation.

05

What researchers measure

Primary outcomes

  1. Rate of Serious Adverse Events

    The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.

    Time frame: 30 days

  2. Number of Participants With Procedural Success

    The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins

    Time frame: 0 days

Other outcomes

  1. Average Power Delivered

    This outcome is the average power delivered for a case.

    Time frame: During Procedure

  2. Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force

    Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force

    Time frame: 0 days

  3. Number of Participants Experiencing Serious Adverse Events Within 30 Days

    Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.

    Time frame: 30 days

  4. Number of Participants Experiencing a Serious Adverse Event Within 1 Year

    Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation

    Time frame: 1 year

  5. One-year Freedom From AF

    One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.

    Time frame: 1 year

  6. One-year Drug-free Success From AF

    One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.

    Time frame: 1 year

  7. Changes in EQ-5D-5L Utility Scores

    Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.

    Time frame: 1 year

  8. Changes in AFEQT Scores

    Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.

    Time frame: 1 year

  9. Health Care Utilization

    Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.

    Time frame: 1 year

  10. Force Time Integral (FTI)

    Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.

    Time frame: 0 days

  11. Average Catheter Temperature

    This outcome is the average temperature (by lesion) for a case.

    Time frame: 0 days

  12. Number of Participants With Recommended Irrigation Flow Rate Used During Procedure

    This outcome is whether or not the recommended irrigation flow rate was used for a case.

    Time frame: 0 days

  13. Contact Force During Procedure

    This outcome is the average contact force for a case.

    Time frame: 0 days

  14. Total Procedure Time

    This outcome is the total procedure time for a case.

    Time frame: 0 days

  15. Ablation Time - First to Last Ablation

    This outcome is the total ablation time for a case. This is the time from first to last ablation.

    Time frame: 0 Days

  16. Fluoroscopy Time

    This outcome is the total fluoroscopy time for a case.

    Time frame: 0 days

  17. Radiofrequency (RF) Application Time

    This outcome is the total RF application time for a case.

    Time frame: 0 days

  18. Number of Participants Using AutoMark

    This outcome is the number of cases using AutoMark.

    Time frame: 0 days

  19. Lesion Index (LSI)

    Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.

    Time frame: 0 days

06

Results

Posted Aug 20, 2019

Participant flow

Enrollment to Catheter Insertion
Participant flow — Enrollment to Catheter Insertion
MilestoneTactiCath SE
Started156
Completed151
Not completed5
Withdrew: Did not meet inc/exc criteria4
Withdrew: Adverse event1
Completed 30-day Visit
Participant flow — Completed 30-day Visit
MilestoneTactiCath SE
Started151
Completed149
Not completed2
Withdrew: Withdrawal by subject1
Withdrew: Missed visit1

Outcome measures

PrimaryRate of Serious Adverse Events

The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.

Time frame:
30 days
Reported as:
Count of participants · Participants
Rate of Serious Adverse Events
ParticipantsTactiCath SE - Safety Population
Rate of Serious Adverse Events7
Statistical analysis
  • TactiCath SE - Safety Population · Binomial Exact Test · p = <0.0001 · Proportion: 0.047
PrimaryNumber of Participants With Procedural Success

The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins

Time frame:
0 days
Reported as:
Count of participants · Participants
Number of Participants With Procedural Success
ParticipantsTactiCath SE
Number of Participants With Procedural Success148
Statistical analysis
  • TactiCath SE · Binomial Exact Test · p = 0.0001 · Proportion: 0.98
Other pre-specifiedAverage Power Delivered

This outcome is the average power delivered for a case.

Time frame:
During Procedure
Reported as:
Median · Watts
Average Power Delivered
WattsRF Population
Average Power Delivered29.0 (26.0 to 32.0)
Other pre-specifiedIndex Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force

Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force

Time frame:
0 days
Reported as:
Count of participants · Participants
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force
ParticipantsRF Population
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force5
Other pre-specifiedNumber of Participants Experiencing Serious Adverse Events Within 30 Days

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants Experiencing Serious Adverse Events Within 30 Days
ParticipantsTactiCath SE
Serious AE Related to Device or Procedure5
Non-Serious AE Related to Device or Procedure23
Other pre-specifiedNumber of Participants Experiencing a Serious Adverse Event Within 1 Year

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants Experiencing a Serious Adverse Event Within 1 Year
ParticipantsTactiCath SE
Serious AE Related to Device or Procedure5
Non-Serious AE Related to Device or Procedure23
Other pre-specifiedOne-year Freedom From AF

One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.

Time frame:
1 year
Reported as:
Count of participants · Participants
One-year Freedom From AF
ParticipantsTactiCath SE
One-year Freedom From AF108
Statistical analysis
  • TactiCath SE · Kaplan-meier survival estimate: 82.2 · 95% CI 74.7 to 87.6Kaplan-Meier estimate of freedom from recurrence at 1-year
Other pre-specifiedOne-year Drug-free Success From AF

One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.

Time frame:
1 year
Reported as:
Count of participants · Participants
One-year Drug-free Success From AF
ParticipantsTactiCath SE Drug-Free Success Population
One-year Drug-free Success From AF90
Statistical analysis
  • TactiCath SE Drug-Free Success Population · Kaplan-meier survival estimate: 68.2 · 95% CI 59.9 to 75.1
Other pre-specifiedChanges in EQ-5D-5L Utility Scores

Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.

Time frame:
1 year
Reported as:
Mean · score on a scale
Changes in EQ-5D-5L Utility Scores
score on a scaleRF Population
Change in EQ-5D-5L Utility from Baseline to 3M0.044 ± 0.108
Change in EQ-5D-5L Utility from Baseline to 6M0.066 ± 0.117
Change in EQ-5D-5L Utility from Baseline to 12M0.032 ± 0.158
Other pre-specifiedChanges in AFEQT Scores

Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.

Time frame:
1 year
Reported as:
Mean · score on a scale
Changes in AFEQT Scores
score on a scaleRF Population
Change from Baseline to 3M25.8 ± 23.8
Change from Baseline to 6M25.2 ± 21.9
Change from Baseline to 12M29.1 ± 23.0
Other pre-specifiedHealth Care Utilization

Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.

Time frame:
1 year
Reported as:
Number · Encounters
Health Care Utilization
EncountersTactiCath SE
Health Care Utilization37
Other pre-specifiedForce Time Integral (FTI)

Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.

Time frame:
0 days
Reported as:
Mean · gram-seconds
Force Time Integral (FTI)
gram-secondsRF Population
Force Time Integral (FTI)161.7 ± 103.7
Other pre-specifiedAverage Catheter Temperature

This outcome is the average temperature (by lesion) for a case.

Time frame:
0 days
Reported as:
Median · degrees celsius
Average Catheter Temperature
degrees celsiusRF Population
Average Catheter Temperature33.4 (32.5 to 34.6)
Other pre-specifiedNumber of Participants With Recommended Irrigation Flow Rate Used During Procedure

This outcome is whether or not the recommended irrigation flow rate was used for a case.

Time frame:
0 days
Reported as:
Count of participants · Participants
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure
ParticipantsRF Population
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure140
Other pre-specifiedContact Force During Procedure

This outcome is the average contact force for a case.

Time frame:
0 days
Reported as:
Mean · grams
Contact Force During Procedure
gramsRF Population
Contact Force During Procedure12.1 ± 4.7
Other pre-specifiedTotal Procedure Time

This outcome is the total procedure time for a case.

Time frame:
0 days
Reported as:
Median · minutes
Total Procedure Time
minutesRF Population
Total Procedure Time159.5 (123.0 to 206.0)
Other pre-specifiedAblation Time - First to Last Ablation

This outcome is the total ablation time for a case. This is the time from first to last ablation.

Time frame:
0 Days
Reported as:
Median · minutes
Ablation Time - First to Last Ablation
minutesRF Population
Ablation Time - First to Last Ablation84.0 (56.0 to 127.0)
Other pre-specifiedFluoroscopy Time

This outcome is the total fluoroscopy time for a case.

Time frame:
0 days
Reported as:
Median · minutes
Fluoroscopy Time
minutesRF Population
Fluoroscopy Time9.0 (5.0 to 16.0)
Other pre-specifiedRadiofrequency (RF) Application Time

This outcome is the total RF application time for a case.

Time frame:
0 days
Reported as:
Median · minutes
Radiofrequency (RF) Application Time
minutesRF Population
Radiofrequency (RF) Application Time35.7 (28.9 to 51.9)
Other pre-specifiedNumber of Participants Using AutoMark

This outcome is the number of cases using AutoMark.

Time frame:
0 days
Reported as:
Count of participants · Participants
Number of Participants Using AutoMark
ParticipantsRF Population
Number of Participants Using AutoMark149
Other pre-specifiedLesion Index (LSI)

Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.

Time frame:
0 days
Reported as:
Mean · units on a scale
Lesion Index (LSI)
units on a scaleRF Population
Lesion Index (LSI)4.3 ± 0.8

Adverse events

Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TactiCath SE0/156 (0%)21/156 (13.5%)25/156 (16%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventTactiCath SE
ArrhythmiasCardiac disorders7/156
Pericardial EffusionCardiac disorders3/156
Cardiac Perforation/TamponadeCardiac disorders2/156
Atrial-Esophageal FistulaGastrointestinal disorders1/156
Cerebrovascular Accident/ StrokeNervous system disorders1/156
CholecystitisHepatobiliary disorders1/156
GastroparesisNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/156
HypertensionVascular disorders1/156
InfectionsGastrointestinal disorders1/156
InfectionsInfections and infestations1/156
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTactiCath SE
PericarditisCardiac disorders6/156
Chest Pain/DiscomfortCardiac disorders5/156
InfectionsInfections and infestations3/156
Vascular Bleeding/Local Hematomas/EcchymosisVascular disorders3/156
Vascular Access ComplicationVascular disorders2/156
Volume OverloadVascular disorders2/156
Allergic ReactionSkin and subcutaneous tissue disorders1/156
Epigastric FullnessGastrointestinal disorders1/156
HypotensionVascular disorders1/156
InfectionsRenal and urinary disorders1/156

Baseline characteristics

Population includes all subjects with device inserted into vasculature.

Age, Categorical
Age, Categorical(Participants)TactiCath SE
<=18 years0
Between 18 and 65 years75
>=65 years76
Age, Continuous
Age, Continuous(years)TactiCath SE
Median65.0 (56.0 to 71.0)
Sex: Female, Male
Sex: Female, Male(Participants)TactiCath SE
Female60
Male91
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TactiCath SE
Hispanic or Latino3
Not Hispanic or Latino125
Unknown or Not Reported23
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TactiCath SE
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White123
More than one race3
Unknown or Not Reported21
Region of Enrollment
Region of Enrollment(participants)TactiCath SE
United States101
Italy12
Australia22
Germany21
BMI
BMI(kg/m^2)TactiCath SE
Mean28.0 ± 5.0
Coronary Artery Disease
Coronary Artery Disease(Participants)TactiCath SE
Count of participants20

11 further baseline measures are reported on the registry.

07

Study locations

21 sites
  • Arkansas Heart Hospital
    Little Rock, Arkansas 72211, United States
  • Scripps Health
    La Jolla, California 92037, United States
  • Sequoia Hospital
    Redwood City, California 94062, United States
  • South Denver Cardiology Associates, P.C.
    Littleton, Colorado 80120, United States
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
  • Central Baptist Hospital
    Lexington, Kentucky 40503, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • New York University Hospital
    New York, New York 10016, United States
  • Mount Sinai Hospital
    New York, New York 10029, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Texas Cardiac Arrhythmia
    Austin, Texas 78705, United States
  • Ashford Hospital
    Adelaide, 5000, Australia
  • Royal Adelaide Hospital
    Adelaide, Australia
  • Royal Melbourne Hospital - City Campus
    Melbourne, 3050, Australia
  • Herzzentrum Leipzig GmbH
    Leipzig, Saxony 04289, Germany
  • Herzzentrum Dresden GmbH Universitätsklinik
    Dresden, 01307, Germany
  • Ospedale San Raffaele
    Milan, Lombardy 20132, Italy
  • Centro Cardiologico Monzino
    Milan, 20138, Italy
08

References and documents

Study documents

  • Study protocol · Mar 6, 2018
  • Statistical analysis plan · Mar 6, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03354663
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Dec 11, 2017
Primary completion
Aug 2, 2018
Completion
Oct 30, 2019
Results posted
Aug 20, 2019
Last update
Oct 11, 2023

Study contacts

Kristin Ruffner, PhD MBA
study director · Abbott

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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