Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
NCT02695277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146
Last updated 2024-10-15
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.
Conditions
- Atrial Fibrillation
- Persistent and Longstanding Persistent Atrial Fibrillation
Interventions
- DEVICE
-
AtriCure Bipolar System
- DEVICE
-
Standard Endocardial Ablation with Catheter
- DEVICE
-
AtriClip® PRO LAA Exclusion System
- DEVICE
-
Endocardial Ablation with Catheter
- DEVICE
-
Repeated Endocardial ablation(s)
Sponsors & Collaborators
-
Cardialysis BV
collaborator INDUSTRY -
AtriCure, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2022-11-30
- Completion
- 2024-09-30
Countries
- Czechia
- Germany
- Netherlands
- Poland
- United Kingdom
Study Locations
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