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CompletedNCT01639495Updated May 15, 2018Results posted

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

A Phase 3 interventional study of THERMOCOOL® SMARTTOUCH™ Catheter in Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by Biosense Webster, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
148
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

Read the detailed description

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

02

Conditions studied

  • Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

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Keywords

  • Drug refractory
  • Atrial fibrillation
  • Antiarrhythmic drug failure
  • Atrial tachyarrhythmias
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 148 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Have had at least 3 atrial fibrillation episodes within 6 months of this study
  • Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
  • 18 years of age or older

Exclusion criteria

Exclusion Criteria including, but not limited to:

  • Have had previous ablation for atrial fibrillation
  • Have take amiodarone within 6 months of this study
  • Have had any heart surgery within the last 60 days
  • Have had a heart attack within the last 60 days
  • Females who are pregnant or breast feeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    THERMOCOOL® SMARTTOUCH™ Catheter

    Device: THERMOCOOL® SMARTTOUCH™ Catheter

Interventions

  • DeviceTHERMOCOOL® SMARTTOUCH™ Catheter

    AF Ablation

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias

    Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures

    Time frame: Day 91-361

  2. Incidence of Primary Adverse Events Within Specified Study Period

    Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.

    Time frame: 12 months post procedure

Secondary outcomes

  1. Peri-procedural Serious Adverse Events

    Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure

    Time frame: Within 8-30 days post procedure

  2. Percentage of Subjects Achieved Acute Effectiveness

    Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins

    Time frame: 5 hours of procedure time

  3. Late Onset Serious Adverse Events

    Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure

    Time frame: From 31 days post procedure to month 12

07

Results

Posted May 15, 2018

Participant flow

This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013.

Participant flow — Overall Study
MilestoneTHERMOCOOL® SMARTTOUCH™ Catheter
Started148
Safety cohort144
Primary effectiveness cohort138
Completed132
Not completed16
Withdrew: Lost to follow-up6
Withdrew: Consented but didn't have study catheter4
Withdrew: Not meeting inclusion/exclusion criteria4
Withdrew: No radiofrequency energy applied2

Outcome measures

PrimaryPercentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias

Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures

Time frame:
Day 91-361
Reported as:
Number · Percentage of participants
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Percentage of participantsTHERMOCOOL® SMARTTOUCH™ Catheter
Primary Effectiveness Cohort60.6 (51.9 to 68.8)
Male60.8 (50.4 to 70.6)
Female60 (43.3 to 75.1)
Statistical analysis
  • THERMOCOOL® SMARTTOUCH™ Catheter · Percentage of subjects: 60.6 · 95% CI 51.9 to 68.8The 2-sided 95% confidence intervals are based on exact binomial
SecondaryPeri-procedural Serious Adverse Events

Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure

Time frame:
Within 8-30 days post procedure
Reported as:
Number · Number of participants
Peri-procedural Serious Adverse Events
Number of participantsTHERMOCOOL® SMARTTOUCH™ Catheter
Number of subjects had peri-procedural SAEs2
Possibly procedure related2
Not-related to procedure or device1
PrimaryIncidence of Primary Adverse Events Within Specified Study Period

Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.

Time frame:
12 months post procedure
Reported as:
Number · percentage of subjects with primary AE
Incidence of Primary Adverse Events Within Specified Study Period
percentage of subjects with primary AETHERMOCOOL® SMARTTOUCH™ Catheter
Primary Safety Cohort17.4 (11.6 to 24.6)
Male13.7 (7.7 to 22.0)
Female26.2 (13.9 to 42.0)
Statistical analysis
  • THERMOCOOL® SMARTTOUCH™ Catheter · Percentage of subjects with primary aes: 17.4 · 95% CI 11.6 to 24.6The 2-sided 95% confidence interval is exact binomial
SecondaryPercentage of Subjects Achieved Acute Effectiveness

Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins

Time frame:
5 hours of procedure time
Reported as:
Number · Percentage of participants
Percentage of Subjects Achieved Acute Effectiveness
Percentage of participantsTHERMOCOOL® SMARTTOUCH™ Catheter
Percentage of Subjects Achieved Acute Effectiveness97.2 (95.6 to 98.2)
Statistical analysis
  • THERMOCOOL® SMARTTOUCH™ Catheter · Percentage of subjects: 97.2 · 95% CI 95.6 to 98.2The 2-sided 95% confidence intervals are exact binomial
SecondaryLate Onset Serious Adverse Events

Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure

Time frame:
From 31 days post procedure to month 12
Reported as:
Number · Number of participants
Late Onset Serious Adverse Events
Number of participantsTHERMOCOOL® SMARTTOUCH™ Catheter
Number of subjects had late onset SAEs27
Procedure related1
Not-related to procedure or device26

Adverse events

Collected over 12 months post procedure. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
THERMOCOOL® SMARTTOUCH™ Catheter—46/144 (31.9%)40/144 (27.8%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventTHERMOCOOL® SMARTTOUCH™ Catheter
ArrhythmiaCardiac disorders16/144
Atrial fibrillationCardiac disorders4/144
PneumoniaInfections and infestations4/144
Atrial flutterCardiac disorders3/144
Pericardial effusionCardiac disorders3/144
Pulmonary oedemaCardiac disorders3/144
Arteriovenous fistulaVascular disorders3/144
HypertensionVascular disorders3/144
Atrioventricular blockCardiac disorders2/144
Chest painCardiac disorders2/144
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTHERMOCOOL® SMARTTOUCH™ Catheter
ArrhythmiaCardiac disorders19/144
Pericardial effusionCardiac disorders4/144
HaematomaVascular disorders4/144
Atrial fibrillationCardiac disorders3/144
Chest painCardiac disorders3/144
HaematuriaRenal and urinary disorders3/144
Fluid overloadCardiac disorders2/144
Oedema peripheralCardiac disorders2/144
PalpitationsCardiac disorders2/144
SyncopeCardiac disorders2/144

Baseline characteristics

All subjects who signed informed consent.

Age, Continuous
Age, Continuous(years)THERMOCOOL® SMARTTOUCH™ Catheter
Mean61.1 ± 10.36
Sex: Female, Male
Sex: Female, Male(Participants)THERMOCOOL® SMARTTOUCH™ Catheter
Female43
Male105
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)THERMOCOOL® SMARTTOUCH™ Catheter
Hispanic or Latino2
Not Hispanic or Latino146
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)THERMOCOOL® SMARTTOUCH™ Catheter
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White147
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)THERMOCOOL® SMARTTOUCH™ Catheter
United States148
08

Study locations

20 sites
  • University of Alabama, Birmingham
    Birmingham, Alabama 35294, United States
  • Stanford University School of Medicine
    Stanford, California 94305, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Piedmont Heart Institute
    Atlanta, Georgia 30309, United States
  • Loyola University Chicago
    Maywood, Illinois 60153, United States
  • University of Kansas Hospitals
    Kansas City, Kansas 66160, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • The Valley Hospital
    Ridgewood, New Jersey 07450, United States
  • Mt. Sinai School of Medicine
    New York, New York 10029, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
  • University of Pennslyvania
    Philadelphia, Pennsylvania 19104, United States
  • Texas Cardiac Arrhythmia Foundation
    Austin, Texas 78705, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23219, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01639495
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Jul 12, 2012
Start date
Jul 1, 2012
Primary completion
Jun 1, 2014
Completion
Oct 1, 2014
Results posted
May 15, 2018
Last update
May 15, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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