Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
NCT02770989 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2018-12-13
Summary
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
Conditions
Interventions
- PROCEDURE
-
Vimecon Laser CAI percutaneous cardiac ablation
The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.
Sponsors & Collaborators
-
Vimecon GmbH
lead INDUSTRY
Principal Investigators
-
René Spaargaren, Dr. · Director Clinical Affairs
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2018-09-30
- Completion
- 2018-09-30
Countries
- Belgium
- Czechia
- Germany
Study Locations
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