Trials / Recruiting
RecruitingNCT07385417
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Cardioangiologisches Centrum Bethanien · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment. Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | AF Ablation | Atrial fibrillation ablation |
Timeline
- Start date
- 2023-04-12
- Primary completion
- 2026-04-12
- Completion
- 2026-04-12
- First posted
- 2026-02-04
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT07385417. Inclusion in this directory is not an endorsement.