Back to resultsFIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (FIRMAP-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FIRM-guided RF ablation
Conventional RF ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Key Inclusion Criteria:
- Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG.
- Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines.
- Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines.
- Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines.
- Left atrial diameter < 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure.
- Sustained AF (>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion.
Key Exclusion Criteria:
- New York Heart Association heart failure (NYHA) Class III - IV.
- Ejection fraction < 40% (within previous six months).
- History of myocardial infarction (MI) within the past three months.
- Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
- Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- Any previous AF catheter ablation.
- History of prior cardioversion for AF lasting > 48 hours.
- Continuous AF episode lasting > 7 days immediately prior to the procedure without a sinus rhythm.
Sites / Locations
- Universitäres Herzzentrum Lübeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FIRM-only
Conventional
Arm Description
Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).
Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.
Outcomes
Primary Outcome Measures
Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure
Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.
Secondary Outcome Measures
Number of Participants With Freedom From Procedure-related Serious Adverse Events
Freedom from procedure-related serious adverse events within one year of the index procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02703454
Brief Title
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Acronym
FIRMAP-AF
Official Title
Focal Impulse and Rotor Modulation (FIRM) Ablation Versus Pulmonary Vein Isolation (PVI) for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FIRM-only
Arm Type
Experimental
Arm Description
Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.
Intervention Type
Procedure
Intervention Name(s)
FIRM-guided RF ablation
Intervention Type
Procedure
Intervention Name(s)
Conventional RF ablation
Primary Outcome Measure Information:
Title
Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure
Description
Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.
Time Frame
3 -12 months post study treatment.
Secondary Outcome Measure Information:
Title
Number of Participants With Freedom From Procedure-related Serious Adverse Events
Description
Freedom from procedure-related serious adverse events within one year of the index procedure
Time Frame
Within 1 year post study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG.
Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines.
Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines.
Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines.
Left atrial diameter < 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure.
Sustained AF (>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion.
Key Exclusion Criteria:
New York Heart Association heart failure (NYHA) Class III - IV.
Ejection fraction < 40% (within previous six months).
History of myocardial infarction (MI) within the past three months.
Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
Any previous AF catheter ablation.
History of prior cardioversion for AF lasting > 48 hours.
Continuous AF episode lasting > 7 days immediately prior to the procedure without a sinus rhythm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland R. Tilz, PD Dr. med.
Organizational Affiliation
Universität zu Lübeck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillipp Sommer, PD Dr. med.
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäres Herzzentrum Lübeck
City
Lübeck
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
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