Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
FIRMap, Rotor, FIRM-guided procedure
Brief summary
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional redo RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
Detailed description
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures. This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
Interventions
PROCEDUREStandard PVI
Standard PVI procedure without FIRMap.
PROCEDUREFIRM-Guided Procedure and PVI
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG. * One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months. * Left atrial diameter \< 6.0 cm via transthoracic echo or transesophageal echo; or \<6.5 cm via CT or MRI with 6 months prior to the procedure. * Sustained spontaneous or induced AF (\>5 min uninterrupted).
Exclusion criteria
* Presence of structural heart disease with clinical significance * NYHA Class IV * Ejection fraction \< 35% * Previous AF ablation within the last 3 months * ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker. * History of myocardial infarction (MI) within the past three (3) months * Atrial clot/thrombus noted within 72 hours of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. | 12 months post procedure | Single procedure freedom from recurrence from 3-12 months post procedure |
| Freedom From Serious Adverse Events Related to the Procedure | 10-day post procedure | Freedom from any procedure-related serious adverse event from 0-10 days post procedure |
Countries
Belgium, Germany, Netherlands, United States
Participant flow
Pre-assignment details
In order to be randomized, subjects must have met the following criteria: 1. Atrial Fibrillation is sustained for at least 5 minutes uninterrupted. 2. Confirmation of Pulmonary Vein reconnection. If Atrial Fibrillation could not be sustained or if Pulmonary Vein reconnection could not be confirmed, the patient was disqualified and were not randomized / enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard PVI Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap. | 133 |
| FIRM-guided Procedure and PVI FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI | 136 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Failed Inclusion/Exclusion Criteria | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 6 |
| Overall Study | Moved to different country | 0 | 1 |
| Overall Study | Trial Screen Failure | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Standard PVI | Total | FIRM-guided Procedure and PVI |
|---|---|---|---|
| Age, Continuous | 65.0 years | 65 years | 65.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 266 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 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 | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 131 Participants | 264 Participants | 133 Participants |
| Region of Enrollment Belgium | 2 participants | 6 participants | 4 participants |
| Region of Enrollment Germany | 98 participants | 192 participants | 94 participants |
| Region of Enrollment Netherlands | 13 participants | 24 participants | 11 participants |
| Region of Enrollment United States | 20 participants | 47 participants | 27 participants |
| Sex: Female, Male Female | 55 Participants | 92 Participants | 37 Participants |
| Sex: Female, Male Male | 78 Participants | 177 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 131 | 2 / 134 |
| other Total, other adverse events | 0 / 131 | 0 / 134 |
| serious Total, serious adverse events | 8 / 131 | 14 / 134 |
Outcome results
Primary
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
Single procedure freedom from recurrence from 3-12 months post procedure
Time frame: 12 months post procedure
Population: Intention to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard PVI | Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. | 72 Participants |
| FIRM-guided Procedure and PVI | Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. | 76 Participants |
Primary
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
Time frame: 10-day post procedure
Population: Intention to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard PVI | Freedom From Serious Adverse Events Related to the Procedure | 120 Participants |
| FIRM-guided Procedure and PVI | Freedom From Serious Adverse Events Related to the Procedure | 125 Participants |
Primary
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
Time frame: 12-month post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard PVI | Freedom From Serious Adverse Events Related to the Procedure | 113 Participants |
| FIRM-guided Procedure and PVI | Freedom From Serious Adverse Events Related to the Procedure | 107 Participants |