Trials / Completed
CompletedNCT03056222
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- I-Med-Pro GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ablation catheter | Ablation of paroxysmal atrial fibrillation |
Timeline
- Start date
- 2017-04-10
- Primary completion
- 2021-08-16
- Completion
- 2021-11-15
- First posted
- 2017-02-17
- Last updated
- 2021-11-19
Locations
11 sites across 4 countries: Belgium, Czechia, Germany, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03056222. Inclusion in this directory is not an endorsement.