Trial Outcomes & Findings for Topera E-FIRM Registry (NCT NCT02386345)

NCT ID: NCT02386345

Last Updated: 2020-01-14

Results Overview

Acute Success was defined as the elimination (by ablation) of all identified rotors

• Recruitment status: COMPLETED
• Target enrollment: 299 participants
• Primary outcome timeframe: day of procedure
• Results posted on: 2020-01-14

Participant Flow

Participant milestones

Measure	Registry Population All patients enrolled in the registry
Overall Study STARTED	299
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	102

Reasons for withdrawal

Measure	Registry Population All patients enrolled in the registry
Overall Study Not treated	14
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	5
Overall Study Repeat Procedure	10
Overall Study Did not complete 12-month follow-up	72

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Registry Population n=299 Participants All patients enrolled in the registry
Age, Continuous	62.5 years STANDARD_DEVIATION 9.0 • n=299 Participants
Sex: Female, Male Female	95 Participants n=299 Participants
Sex: Female, Male Male	204 Participants n=299 Participants
Body Mass Index	29.5 kg/m^2 STANDARD_DEVIATION 4.9 • n=299 Participants
New York Heart Association Class Class I	94 Participants n=299 Participants
New York Heart Association Class Class II	79 Participants n=299 Participants
New York Heart Association Class Class III	37 Participants n=299 Participants
New York Heart Association Class Not reported	89 Participants n=299 Participants
Type of Atrial Fibrillation Paroxysmal	38 Participants n=299 Participants
Type of Atrial Fibrillation Persistent	248 Participants n=299 Participants
Type of Atrial Fibrillation Long lasting	11 Participants n=299 Participants
Type of Atrial Fibrillation Not reported	2 Participants n=299 Participants
Left Ventricle Ejection Fraction	55.8 percent STANDARD_DEVIATION 8.5 • n=299 Participants
Left Atrium Diamter	47.2 millimeter STANDARD_DEVIATION 6.1 • n=299 Participants

PRIMARY outcome

Timeframe: day of procedure

Acute Success was defined as the elimination (by ablation) of all identified rotors

Outcome measures

Measure	Analysis Population n=285 Participants All treated patients
Number of Participants With Acute Success	165 Participants

PRIMARY outcome

Timeframe: 12-months after index procedure

Single procedure freedom from atrial fibrillation recurrence

Outcome measures

Measure	Analysis Population n=242 Participants All treated patients
Number of Participants With 12-Month Success	101 Participants

PRIMARY outcome

Timeframe: 7 days after index procedure

Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure

Outcome measures

Measure	Analysis Population n=271 Participants All treated patients
Number of Participants With Acute Safety Success	257 Participants

PRIMARY outcome

Timeframe: 12-months after index procedure

Success was defined as freedom from Serious Adverse Events at 12-months after index procedure

Outcome measures

Measure	Analysis Population n=218 Participants All treated patients
Number of Participants With 12-Month Safety Success	184 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-months after index procedure

Success was defined as freedom from Serious Adverse Events at 6-months after index procedure

Outcome measures

Measure	Analysis Population n=256 Participants All treated patients
Number of Participants With 6-Month Safety Success	232 Participants

Adverse Events

Registry Population

Serious events: 34 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Registry Population n=299 participants at risk All patients enrolled in the registry
Cardiac disorders Recurrent Atrial Fibrillation	3.0% 9/299 • Number of events 13 • 12-months
Vascular disorders Bleeding with medical intervention	2.3% 7/299 • Number of events 8 • 12-months
Vascular disorders Pericardial effusion	0.67% 2/299 • Number of events 2 • 12-months
Cardiac disorders Atrioesophageal fistula	0.33% 1/299 • Number of events 1 • 12-months
Cardiac disorders Transient ischemic attack	1.0% 3/299 • Number of events 3 • 12-months
Vascular disorders Stroke	0.33% 1/299 • Number of events 1 • 12-months
Surgical and medical procedures Cardiac Resynchronization Therapy Pacemaker implantation	0.67% 2/299 • Number of events 2 • 12-months
Surgical and medical procedures Cavotricuspid isthmus ablation	0.67% 2/299 • Number of events 2 • 12-months
Vascular disorders Dyspnea	0.33% 1/299 • Number of events 1 • 12-months
Cardiac disorders Heart rhythm disorder	0.33% 1/299 • Number of events 2 • 12-months
Vascular disorders High position right hemotoma	0.33% 1/299 • Number of events 1 • 12-months
Vascular disorders Intramuscular hemorrhage	0.33% 1/299 • Number of events 1 • 12-months
Surgical and medical procedures Lip laceration	0.33% 1/299 • Number of events 1 • 12-months
Cardiac disorders Non-sustained ventricular tachycardia	0.33% 1/299 • Number of events 1 • 12-months
Surgical and medical procedures Pacemaker implantation	0.33% 1/299 • Number of events 1 • 12-months

Other adverse events

Adverse event data not reported

Additional Information

Clinical Program Director

Abbott

Phone: 6517566717

Email: kristin.ruffner@abbott.com

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