Trial Outcomes & Findings for Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (NCT NCT02799043)
NCT ID: NCT02799043
Last Updated: 2024-09-19
Results Overview
Single procedure freedom from recurrence from 3-12 months post procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
269 participants
Primary outcome timeframe
12 months post procedure
Results posted on
2024-09-19
Participant Flow
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.
Participant milestones
| Measure |
Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
136
|
|
Overall Study
Treated
|
131
|
134
|
|
Overall Study
COMPLETED
|
122
|
121
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Moved to different country
|
0
|
1
|
|
Overall Study
Trial Screen Failure
|
1
|
0
|
|
Overall Study
Failed Inclusion/Exclusion Criteria
|
2
|
2
|
Baseline Characteristics
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Baseline characteristics by cohort
| Measure |
Standard PVI
n=133 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=136 Participants
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
65.5 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
27 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
98 participants
n=5 Participants
|
94 participants
n=7 Participants
|
192 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post procedurePopulation: Intention to Treat
Single procedure freedom from recurrence from 3-12 months post procedure
Outcome measures
| Measure |
Standard PVI
n=122 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=120 Participants
FIRM-guided procedure followed by PVI.
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.
|
72 Participants
|
76 Participants
|
PRIMARY outcome
Timeframe: 10-day post procedurePopulation: Intention to Treat
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
Outcome measures
| Measure |
Standard PVI
n=128 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=134 Participants
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
|---|---|---|
|
Freedom From Serious Adverse Events Related to the Procedure
|
120 Participants
|
125 Participants
|
PRIMARY outcome
Timeframe: 12-month post procedureFreedom from any procedure-related serious adverse event from 0-12 months post procedure
Outcome measures
| Measure |
Standard PVI
n=121 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=121 Participants
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
|---|---|---|
|
Freedom From Serious Adverse Events Related to the Procedure
|
113 Participants
|
107 Participants
|
Adverse Events
Standard PVI
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
FIRM-guided Procedure and PVI
Serious events: 14 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Standard PVI
n=131 participants at risk
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=134 participants at risk
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
|
|---|---|---|
|
Blood and lymphatic system disorders
Vascular pseudoaneurysm
|
0.76%
1/131 • Number of events 1 • 12 months
|
1.5%
2/134 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Anesthetic complication
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.76%
1/131 • Number of events 1 • 12 months
|
0.00%
0/134 • 12 months
|
|
Cardiac disorders
Catheter site hemorrhage
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Vascular disorders
Cerebral infarction
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Vascular disorders
Cerebrovascular accident
|
0.76%
1/131 • Number of events 1 • 12 months
|
0.00%
0/134 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
2/131 • Number of events 2 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Dyspnea
|
0.00%
0/131 • 12 months
|
1.5%
2/134 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Esophageal stent insertion
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/131 • 12 months
|
1.5%
2/134 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Peripheral artery stenosis
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.5%
2/131 • Number of events 2 • 12 months
|
0.00%
0/134 • 12 months
|
|
Renal and urinary disorders
Prostatitis
|
0.76%
1/131 • Number of events 1 • 12 months
|
0.00%
0/134 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
General disorders
Pyrexia
|
0.00%
0/131 • 12 months
|
0.75%
1/134 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus node dysfunction
|
0.00%
0/131 • 12 months
|
1.5%
2/134 • Number of events 2 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER