Trial Outcomes & Findings for Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (NCT NCT02274857)
NCT ID: NCT02274857
Last Updated: 2020-02-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Within 7-10 days of the Procedure
Results posted on
2020-02-07
Participant Flow
Participant milestones
| Measure |
Standard PVI Ablation
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent atrial fibrillation (AF).
Standard PVI Ablation: Standard PVI procedure without Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap).
|
FIRM-guided Procedure and PVI
Focal Impulse and Rotor Modulation (FIRM)-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
171
|
|
Overall Study
Completed Per Protocol
|
102
|
114
|
|
Overall Study
COMPLETED
|
159
|
165
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
Reasons for withdrawal
| Measure |
Standard PVI Ablation
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent atrial fibrillation (AF).
Standard PVI Ablation: Standard PVI procedure without Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap).
|
FIRM-guided Procedure and PVI
Focal Impulse and Rotor Modulation (FIRM)-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Trial screen failure
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
2
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Baseline characteristics by cohort
| Measure |
Standard PVI Ablation
n=179 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=171 Participants
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
64.2 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
327 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
330 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
27 participants
n=99 Participants
|
23 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
80 participants
n=107 Participants
|
160 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
72 participants
n=99 Participants
|
68 participants
n=107 Participants
|
140 participants
n=206 Participants
|
|
BMI
|
31.12 kg/m^2
STANDARD_DEVIATION 5.63 • n=99 Participants
|
31.17 kg/m^2
STANDARD_DEVIATION 5.59 • n=107 Participants
|
31.15 kg/m^2
STANDARD_DEVIATION 5.60 • n=206 Participants
|
|
NYHA Classification
Class I
|
63 category
n=99 Participants
|
53 category
n=107 Participants
|
116 category
n=206 Participants
|
|
NYHA Classification
Class II
|
52 category
n=99 Participants
|
63 category
n=107 Participants
|
115 category
n=206 Participants
|
|
NYHA Classification
Class III
|
18 category
n=99 Participants
|
17 category
n=107 Participants
|
35 category
n=206 Participants
|
|
Largest Left Atrial Diameter
|
45.63 mm
STANDARD_DEVIATION 9.63 • n=99 Participants
|
48.07 mm
STANDARD_DEVIATION 7.65 • n=107 Participants
|
46.82 mm
STANDARD_DEVIATION 8.80 • n=206 Participants
|
|
LV Ejection Fraction
|
54.5 %
STANDARD_DEVIATION 8.9 • n=99 Participants
|
53.8 %
STANDARD_DEVIATION 8.0 • n=107 Participants
|
54.2 %
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Prior and concomitant antiarrhythmic drugs (AAD)
Class I AAD
|
29 participants
n=99 Participants
|
32 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Prior and concomitant antiarrhythmic drugs (AAD)
Class 2 AAD
|
115 participants
n=99 Participants
|
106 participants
n=107 Participants
|
221 participants
n=206 Participants
|
|
Prior and concomitant antiarrhythmic drugs (AAD)
Class 3 AAD
|
67 participants
n=99 Participants
|
69 participants
n=107 Participants
|
136 participants
n=206 Participants
|
|
Prior and concomitant antiarrhythmic drugs (AAD)
Class 4 AAD
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Hospitalizations for Cardiac Arrhythmias within 6 months of screening
|
59 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Treated for atrial fibrillation in the 6 months prior to enrollment
|
85.4 %
n=99 Participants
|
88.9 %
n=107 Participants
|
87.1 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Cardiovascular
|
72.1 %
n=99 Participants
|
67.8 %
n=107 Participants
|
70.0 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
CNS/Neurological
|
10.6 %
n=99 Participants
|
11.7 %
n=107 Participants
|
11.1 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Dermatologic
|
5.0 %
n=99 Participants
|
4.7 %
n=107 Participants
|
4.9 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Drug Allergy
|
3.4 %
n=99 Participants
|
1.8 %
n=107 Participants
|
2.6 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Endocrine/Metabolic
|
37.4 %
n=99 Participants
|
30.4 %
n=107 Participants
|
34.0 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Eyes/Ears/Nose/Throat
|
11.2 %
n=99 Participants
|
12.9 %
n=107 Participants
|
12.0 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Gastrointestinal
|
18.4 %
n=99 Participants
|
23.4 %
n=107 Participants
|
20.9 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Genitourinary
|
8.9 %
n=99 Participants
|
12.9 %
n=107 Participants
|
10.9 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Hematologic
|
5.0 %
n=99 Participants
|
4.1 %
n=107 Participants
|
4.6 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Hepatic
|
2.2 %
n=99 Participants
|
2.9 %
n=107 Participants
|
2.6 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Immunological
|
3.9 %
n=99 Participants
|
4.7 %
n=107 Participants
|
4.3 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Malignancy
|
5.6 %
n=99 Participants
|
5.3 %
n=107 Participants
|
5.4 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Musculoskeletal
|
26.3 %
n=99 Participants
|
28.1 %
n=107 Participants
|
27.1 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Psychiatric
|
7.3 %
n=99 Participants
|
5.8 %
n=107 Participants
|
6.6 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Renal
|
8.9 %
n=99 Participants
|
11.1 %
n=107 Participants
|
10.0 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Respiratory
|
24.0 %
n=99 Participants
|
22.8 %
n=107 Participants
|
23.4 %
n=206 Participants
|
|
History of significant past and/or concomitant diseases or past surgeries
Other
|
21.2 %
n=99 Participants
|
26.3 %
n=107 Participants
|
23.7 %
n=206 Participants
|
|
Subjects that had LV Ejection Fraction Measured
|
170 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
330 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 7-10 days of the ProcedurePopulation: Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
Outcome measures
| Measure |
Standard PVI Ablation
n=179 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=171 Participants
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
|
92.7 % of participants
|
88.9 % of participants
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations
Outcome measures
| Measure |
Standard PVI Ablation
n=179 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=171 Participants
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
|
76.9 % of participants
|
71.8 % of participants
|
PRIMARY outcome
Timeframe: 3-12 months post study treatmentPopulation: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
Outcome measures
| Measure |
Standard PVI Ablation
n=179 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=171 Participants
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
|
67.5 % of participants
|
69.3 % of participants
|
PRIMARY outcome
Timeframe: 3 to 12 months post study treatmentPopulation: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
Outcome measures
| Measure |
Standard PVI Ablation
n=163 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=167 Participants
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
|
146 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: Immediately post procedurePopulation: ITT
Outcome measures
| Measure |
Standard PVI Ablation
n=171 Participants
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including 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 Millivolts
|
86.1 % of participants
Interval 79.7 to 91.1
|
—
|
Adverse Events
Standard PVI Ablation
Serious events: 19 serious events
Other events: 0 other events
Deaths: 1 deaths
FIRM-guided Procedure and PVI
Serious events: 28 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Standard PVI Ablation
n=179 participants at risk
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap.
|
FIRM-guided Procedure and PVI
n=171 participants at risk
FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula operation
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
1.7%
3/179 • Number of events 5 • 1 year
|
1.8%
3/171 • Number of events 4 • 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
2.8%
5/179 • Number of events 8 • 1 year
|
1.8%
3/171 • Number of events 3 • 1 year
|
|
General disorders
C-reactive protein increased
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Chest pain
|
0.00%
0/179 • 1 year
|
1.2%
2/171 • Number of events 2 • 1 year
|
|
Vascular disorders
Cerebrovascular accident
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.00%
0/171 • 1 year
|
|
Cardiac disorders
Fluid overload
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroparesis postoperative
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.00%
0/171 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
3/179 • Number of events 3 • 1 year
|
4.7%
8/171 • Number of events 8 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis infective
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial disease
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.00%
0/171 • 1 year
|
|
Cardiac disorders
Pericardial hemmorrhage
|
1.1%
2/179 • Number of events 2 • 1 year
|
0.00%
0/171 • 1 year
|
|
General disorders
Peritoneal hemorrhage
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/179 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus Bradycardia
|
0.56%
1/179 • Number of events 1 • 1 year
|
0.58%
1/171 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vessel puncture site hematoma
|
0.56%
1/179 • Number of events 1 • 1 year
|
1.2%
2/171 • Number of events 2 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All manuscripts should be submitted to the sponsor for review and comment prior to submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER