Trial Outcomes & Findings for Topera C-FIRM Registry (NCT NCT02407249)

NCT ID: NCT02407249

Last Updated: 2019-10-16

Results Overview

Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure

Recruitment status

COMPLETED

Target enrollment

73 participants

Primary outcome timeframe

day of procedure

Results posted on

2019-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Registry Population All participants enrolled in the C-FIRM registry.
Overall Study STARTED	73
Overall Study Treated	60
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Registry Population All participants enrolled in the C-FIRM registry.
Overall Study Did not complete 12-month follow-up	13
Overall Study Not treated	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Registry Population n=73 Participants All participants enrolled in the C-FIRM registry.
Age, Continuous	62.2 years STANDARD_DEVIATION 9.7 • n=73 Participants
Sex: Female, Male Female	20 Participants n=73 Participants
Sex: Female, Male Male	53 Participants n=73 Participants
Body Mass Index	29.0 kg/m^2 STANDARD_DEVIATION 5.1 • n=73 Participants
New York Heart Association Class Class I	21 Participants n=73 Participants
New York Heart Association Class Class II	20 Participants n=73 Participants
New York Heart Association Class Class III	5 Participants n=73 Participants
New York Heart Association Class Not reported	27 Participants n=73 Participants
Type of Atrial Fibrillation Paroxysmal	32 Participants n=73 Participants
Type of Atrial Fibrillation Persistent	40 Participants n=73 Participants
Type of Atrial Fibrillation Not reported	1 Participants n=73 Participants
Left Ventricle Ejection Fraction	57.8 percent STANDARD_DEVIATION 9.0 • n=73 Participants
Left Atrium Diamter	45.2 millimeter STANDARD_DEVIATION 7.5 • n=73 Participants

PRIMARY outcome

Timeframe: day of procedure

Population: All treated patients

Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure

Outcome measures

Outcome measures
Measure	Analysis Population n=60 Participants All treated patients
Number of Participants With Acute Success	53 Participants

PRIMARY outcome

Timeframe: 12 months after initial AF ablation

Population: Treated patients with 12-month follow-up data

Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.

Outcome measures

Outcome measures
Measure	Analysis Population n=48 Participants All treated patients
Number of Participants With 12-Month Effectiveness	34 Participants

PRIMARY outcome

Timeframe: 7 days after initial AF ablation

Population: Analysis population for whom data are available

Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation

Outcome measures

Outcome measures
Measure	Analysis Population n=57 Participants All treated patients
Number of Participants With Acute Safety Success	56 Participants

PRIMARY outcome

Timeframe: 12-months after index procedure

Population: Treated patients for whom 12-month safety data is available

12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure

Outcome measures

Outcome measures
Measure	Analysis Population n=48 Participants All treated patients
Number of Participants With 12-Month Safety Success	45 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-months after index procedure

Population: Treated patients for whom 6-month safety data is available

6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure

Outcome measures

Outcome measures
Measure	Analysis Population n=54 Participants All treated patients
Number of Participants With 6-month Safety Success	51 Participants

Adverse Events

Enrolled Population

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled Population n=73 participants at risk All patients enrolled in the registry
Eye disorders Amaurosis fugax / volatile blindness right eye	1.4% 1/73 • Number of events 1 • 12-months
Vascular disorders Strong hematoma left groin/knee	1.4% 1/73 • Number of events 1 • 12-months
Cardiac disorders Ventricular extrasystole ablatiion	1.4% 1/73 • Number of events 1 • 12-months

Other adverse events

Adverse event data not reported

Additional Information

Clinical Program Director

Abbott

Phone: 6517566717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Manuscripts prepared for publication will be submitted to sponsor for review and comments prior to submission to the publisher. This condition should not be construed as a means of restricting publication but is intended solely to assure mutual concurrence regarding data, evaluations, and conclusion, to provide an opportunity to share with the investigator any new and/or unpublished information of which he/she may be unaware, and to assure regulatory compliance of the results presented.
Publication restrictions are in place

Restriction type: OTHER