Trials / Completed
CompletedNCT03064451
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF Using the RHYTHMFINDER-192
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is investigational, while the CARTOFINDER™ system is CE marked in Europe. All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening. The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12 months postprocedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | cartofinder guided ablation followed by PVI | cartofinder guided ablation followed by PVI |
Timeline
- Start date
- 2017-02-22
- Primary completion
- 2019-04-10
- Completion
- 2019-04-10
- First posted
- 2017-02-27
- Last updated
- 2020-05-11
- Results posted
- 2020-04-21
Locations
7 sites across 4 countries: Belgium, Canada, Czechia, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03064451. Inclusion in this directory is not an endorsement.