Paroxysmal Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREFIRM-guided RF ablation
PROCEDUREConventional RF ablation
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | 3 -12 months post study treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Procedure-related Serious Adverse Events | Within 1 year post study treatment | Freedom from procedure-related serious adverse events within one year of the index procedure |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FIRM-only Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).
FIRM-guided RF ablation | 24 |
| Conventional Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.
Conventional RF ablation | 27 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not treated | 1 | 3 |
| Overall Study | Study discontinuation | 5 | 8 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | FIRM-only | Conventional | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11.4 | 65 years STANDARD_DEVIATION 9.7 | 63 years STANDARD_DEVIATION 10.6 |
| Anti-Arrhythmic Use at Baseline: Amiodarone No | 22 Participants | 25 Participants | 47 Participants |
| Anti-Arrhythmic Use at Baseline: Amiodarone Unknown | 0 Participants | 2 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Amiodarone Yes | 2 Participants | 0 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Dronedarone No | 24 Participants | 25 Participants | 49 Participants |
| Anti-Arrhythmic Use at Baseline: Dronedarone Unknown | 0 Participants | 2 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Dronedarone Yes | 0 Participants | 0 Participants | 0 Participants |
| Anti-Arrhythmic Use at Baseline: Flecainide No | 20 Participants | 18 Participants | 38 Participants |
| Anti-Arrhythmic Use at Baseline: Flecainide Unknown | 0 Participants | 2 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Flecainide Yes | 4 Participants | 7 Participants | 11 Participants |
| Anti-Arrhythmic Use at Baseline: Propafenone No | 23 Participants | 25 Participants | 48 Participants |
| Anti-Arrhythmic Use at Baseline: Propafenone Unknown | 0 Participants | 2 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Propafenone Yes | 1 Participants | 0 Participants | 1 Participants |
| Anti-Arrhythmic Use at Baseline: Sotalol No | 24 Participants | 23 Participants | 47 Participants |
| Anti-Arrhythmic Use at Baseline: Sotalol Unknown | 0 Participants | 2 Participants | 2 Participants |
| Anti-Arrhythmic Use at Baseline: Sotalol Yes | 0 Participants | 2 Participants | 2 Participants |
| Body Mass Index (BMI) | 27 kg/m^2 STANDARD_DEVIATION 6.2 | 28 kg/m^2 STANDARD_DEVIATION 5.5 | 28 kg/m^2 STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class I | 2 Participants | 0 Participants | 2 Participants |
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class II | 8 Participants | 7 Participants | 15 Participants |
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class III | 14 Participants | 18 Participants | 32 Participants |
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class IV | 0 Participants | 1 Participants | 1 Participants |
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Unknown | 0 Participants | 1 Participants | 1 Participants |
| History of Arterial Hypertension No | 9 Participants | 8 Participants | 17 Participants |
| History of Arterial Hypertension Unknown | 4 Participants | 6 Participants | 10 Participants |
| History of Arterial Hypertension Yes | 11 Participants | 13 Participants | 24 Participants |
| History of Chronic Renal Insufficiency No | 18 Participants | 18 Participants | 36 Participants |
| History of Chronic Renal Insufficiency Unknown | 4 Participants | 6 Participants | 10 Participants |
| History of Chronic Renal Insufficiency Yes | 2 Participants | 3 Participants | 5 Participants |
| History of Coronary Artery Disease No | 12 Participants | 13 Participants | 25 Participants |
| History of Coronary Artery Disease Unknown | 4 Participants | 6 Participants | 10 Participants |
| History of Coronary Artery Disease Yes | 8 Participants | 8 Participants | 16 Participants |
| Left Atrial Diameter | 44 mm STANDARD_DEVIATION 5.5 | 44 mm STANDARD_DEVIATION 7.3 | 44 mm STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 4 / 24 | 1 / 27 |
| serious Total, serious adverse events | 12 / 24 | 4 / 27 |
Outcome results
Primary
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.
Time frame: 3 -12 months post study treatment.
Population: Patients with 12-month follow-up data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FIRM-only | Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | 5 Participants |
| Conventional | Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | 8 Participants |
Secondary
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
Time frame: Within 1 year post study treatment
Population: Subjects with 12 month safety data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FIRM-only | Number of Participants With Freedom From Procedure-related Serious Adverse Events | 12 Participants |
| Conventional | Number of Participants With Freedom From Procedure-related Serious Adverse Events | 14 Participants |