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CompletedNCT02274857REAFFIRMUpdated Feb 7, 2020Results posted

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

An interventional study of Standard PVI Ablation and FIRM-Guided Procedure and PVI in Persistent Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 18 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-07.

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

Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

02

Conditions studied

  • Persistent Atrial Fibrillation

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Keywords

  • Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)
  • Rotor
  • FIRM-guided procedure
  • REAFFIRM
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 350 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
  • Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
  • Left atrial diameter \< 6.0 cm

Key Exclusion Criteria:

  • Previous AF Ablation
  • Presence of structural heart disease
  • New York Heart Association (NYHA) Class IV.
  • Ejection fraction \< 35%.
  • History of myocardial infarction (MI) within the past three months.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (actual)

Study arms

  • Active comparator
    Standard PVI Ablation

    Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.

    Procedure: Standard PVI Ablation

  • Experimental
    FIRM-guided Procedure and PVI

    FIRM-guided procedure followed by standard catheter ablation including PVI.

    Procedure: FIRM-Guided Procedure and PVI

Interventions

  • ProcedureStandard PVI Ablation

    Standard PVI procedure without FIRMap.

    Also known as: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping

  • ProcedureFIRM-Guided Procedure and PVI

    FIRM-guided procedure followed by conventional ablation including PVI.

    Also known as: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping, FIRMap

06

What researchers measure

Primary outcomes

  1. Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure

    Time frame: Within 7-10 days of the Procedure

  2. Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.

    Time frame: 3-month follow up

  3. Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.

    Time frame: 3-12 months post study treatment

  4. Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure

    Time frame: 3 to 12 months post study treatment

Secondary outcomes

  1. Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts

    Time frame: Immediately post procedure

07

Results

Posted Feb 7, 2020

Participant flow

Participant flow — Overall Study
MilestoneStandard PVI AblationFIRM-guided Procedure and PVI
Started179171
Completed per protocol102114
Completed159165
Not completed206
Withdrew: Adverse event10
Withdrew: Death12
Withdrew: Lost to follow-up30
Withdrew: Physician decision20
Withdrew: Trial screen failure02
Withdrew: Withdrawal by subject112
Withdrew: Other20

Outcome measures

PrimaryFreedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Time frame:
Within 7-10 days of the Procedure
Reported as:
Number · % of participants
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
% of participantsStandard PVI AblationFIRM-guided Procedure and PVI
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure92.788.9
Statistical analysis
  • Standard PVI Ablation vs FIRM-guided Procedure and PVI · Chi-squared · p = 0.2179
PrimarySingle-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Time frame:
3-month follow up
Reported as:
Number · % of participants
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
% of participantsStandard PVI AblationFIRM-guided Procedure and PVI
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.76.971.8
Statistical analysis
  • Standard PVI Ablation vs FIRM-guided Procedure and PVI · Chi-squared · p = 0.2782
PrimarySingle-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Time frame:
3-12 months post study treatment
Reported as:
Number · % of participants
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
% of participantsStandard PVI AblationFIRM-guided Procedure and PVI
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.67.569.3
Statistical analysis
  • Standard PVI Ablation vs FIRM-guided Procedure and PVI · Chi-squared · p = 0.7266
PrimaryFreedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
Time frame:
3 to 12 months post study treatment
Reported as:
Count of participants · Participants
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
ParticipantsStandard PVI AblationFIRM-guided Procedure and PVI
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure146144
Statistical analysis
  • Standard PVI Ablation vs FIRM-guided Procedure and PVI · Chi-squared · p = 0.3522
SecondaryEvaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts
Time frame:
Immediately post procedure
Reported as:
Number · % of participants
Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts
% of participantsFIRM-guided Procedure and PVI
Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts86.1 (79.7 to 91.1)

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard PVI Ablation1/179 (0.6%)19/179 (10.6%)0/179 (0%)
FIRM-guided Procedure and PVI2/171 (1.2%)28/171 (16.4%)0/171 (0%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventStandard PVI AblationFIRM-guided Procedure and PVI
Pericardial effusionCardiac disorders3/1798/171
Atrial tachycardiaCardiac disorders5/1793/171
Atrial flutterCardiac disorders3/1793/171
Chest painCardiac disorders0/1792/171
Vessel puncture site hematomaInjury, poisoning and procedural complications1/1792/171
Pericardial hemmorrhageCardiac disorders2/1790/171
Acute kidney injuryRenal and urinary disorders0/1791/171
AnemiaBlood and lymphatic system disorders0/1791/171
Arteriovenous fistula operationInjury, poisoning and procedural complications0/1791/171
Atrial fibrillationCardiac disorders0/1791/171

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard PVI AblationFIRM-guided Procedure and PVITotal
Mean62.7 ± 8.764.2 ± 8.463.4 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Standard PVI AblationFIRM-guided Procedure and PVITotal
Female524597
Male127126253
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Standard PVI AblationFIRM-guided Procedure and PVITotal
Hispanic or Latino415
Not Hispanic or Latino167160327
Unknown or Not Reported81018
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard PVI AblationFIRM-guided Procedure and PVITotal
American Indian or Alaska Native022
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American123
White171159330
More than one race123
Unknown or Not Reported6612
Region of Enrollment
Region of Enrollment(participants)Standard PVI AblationFIRM-guided Procedure and PVITotal
Netherlands272350
United States8080160
Germany7268140
BMI
BMI(kg/m^2)Standard PVI AblationFIRM-guided Procedure and PVITotal
Mean31.12 ± 5.6331.17 ± 5.5931.15 ± 5.60
NYHA Classification
NYHA Classification(category)Standard PVI AblationFIRM-guided Procedure and PVITotal
Class I6353116
Class II5263115
Class III181735
Largest Left Atrial Diameter
Largest Left Atrial Diameter(mm)Standard PVI AblationFIRM-guided Procedure and PVITotal
Mean45.63 ± 9.6348.07 ± 7.6546.82 ± 8.80

6 further baseline measures are reported on the registry.

08

Study locations

18 sites
  • Arizona Heart Rhythm Center
    Phoenix, Arizona 85013, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92658, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Indiana University - Krannert Institute of Cardiology
    Indianapolis, Indiana 46202, United States
  • St. Vincent Hospital
    Indianapolis, Indiana 46260, United States
  • The Johns Hopkins Hospital
    Baltimore, Maryland, United States
  • Hackensack UMC
    Hackensack, New Jersey, United States
  • Weill Medical College at Cornell University
    New York, New York 10065, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Geisinger Wyoming Valley Medical Center
    Wilkes-Barre, Pennsylvania, United States
  • Herz- und Diabeteszentrum Bad Oeynhausen
    Bad Oeynhausen, Minden-Lübbecke 32545, Germany
  • Unfallkrankenhaus Berlin
    Berlin, 12683, Germany
  • Klinikum Coburg GmbH
    Coburg, 96450, Germany
  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
    Dresden, 01099, Germany
  • Städtisches Klinikum Karlsruhe gGmbH
    Karlsruhe, Germany
  • Leipzig Heart Institute GmbH
    Leipzig, 04289, Germany
  • Kardiologische Gemeinschaftspraxis am Park Sanssouci
    Potsdam, 14471, Germany
  • Erasmus Medical Center
    Rotterdam, Netherlands
09

References and documents

Study documents

  • Statistical analysis plan · Aug 5, 2014
  • Study protocol · Jun 17, 2014

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02274857
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Oct 2014
Primary completion
Nov 10, 2018
Completion
Nov 10, 2018
Results posted
Feb 7, 2020
Last update
Feb 7, 2020

Study contacts

Johannes Brachmann, MD
principal investigator · Klinikum Coburg GmbH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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