Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

AtriCure, Inc.12 sites in 5 countries146 target enrollmentNovember 2015

ConditionsAtrial Fibrillation Persistent and Longstanding Persistent Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: AtriCure, Inc.
Enrollment: 146
Locations: 12
Primary Endpoint: Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

September 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AtriCure, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has a history of symptomatic Persistent AF and a left atrium (LA) \> 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement
•Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
•Patient is mentally able and willing to give informed consent

Exclusion Criteria

•Patient has longstanding persistent AF \> 10 years
•Patient presenting with paroxysmal AF
•Patient with persistent AF and a LA-diameter ≤ 4cm
•AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
•Patient underwent previous ablation procedure or heart surgery
•Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
•Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)
•Body mass index \> 35
•LA Diameter \> 6 cm
•Left ventricular ejection fraction \< 30 %

Outcomes

Primary Outcomes

Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).

Time Frame: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)

Secondary Outcomes

Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs.(Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure))