The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF.
NCT07077811 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2025-07-22
Summary
The goal of this clinical trial is to evaluate the the mid- and long-term clinical efficacy and safety of pulsed field catheter ablation for patients with persistent atrial fibrillation and HFpEF. The main questions it aims to answer are:
* What are the differences between the effects of pulsed field ablation and drug therapy?
* Which risk factors affecting the outcome of atrial fibrillation ablation, postoperative recurrence, and improvement of cardiac function? Researchers will compare pulsed field ablation to drug therapy to provide some theoretical basis and clinical evidence for the treatment strategy of patients with atrial fibrillation and HFpEF.
This study selected patients with persistent AF and HFpEF and divided them into a drug group (treated with class I or class III antiarrhythmic drugs) and a surgical group (Medtronic Pulse Select pulsed field ablation).
Conditions
- Cardiovascular Diseases
- Heart Failure
- Atrial Fibrillation (AF)
- HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
- PROCEDURE
-
pulsed field ablation
Medtronic Pulse Select pulsed field ablation
- DRUG
-
antiarrhythmic drug
treated with class I or class III antiarrhythmic drugs
Sponsors & Collaborators
-
Affiliated Hospital of Nantong University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2027-06-01
- Completion
- 2028-06-01
Countries
- China
Study Locations
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