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OFF-MEDReducing Blanking-Period Recurrence of Atrial Arrhythmia with Renal Denervation and Pulsed Field Ablation in Persistent Atrial Fibrillation Patients

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Study Aim

This study aims to reduce the recurrence of blanking-period atrial arrhythmia by combining renal denervation and pulsed field ablation in individuals with persistent atrial fibrillation.

What is being tested

renal denervation

+ Pulsed-Field Ablation (PFA)

Procedure
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorShanghai Chest Hospital
Study ContactWenzheng Han, M.D, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating persistent atrial fibrillation, a type of irregular heartbeat, in adults aged 18 and above. The study combines two treatments: renal denervation (RDN) and pulsed-field ablation (PFA). The main goal is to see if using both treatments together can reduce the recurrence of irregular heartbeats during the 90-day 'blanking period' following the first-time ablation procedure, while patients are not taking any anti-arrhythmic drugs. This research is important as it may offer a new approach to managing persistent atrial fibrillation and potentially improve patient care.

Official TitleThe Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Blanking Period Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation: An OFF-MED Trial
NCT07320768
Principal SponsorShanghai Chest Hospital
Study ContactWenzheng Han, M.D, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
Age > 18 years.
Patients with persistent atrial fibrillation undergoing first-time catheter ablation (defined as any episode lasting ≥7 days).
Symptomatic atrial fibrillation refractory to or intolerant of at least one class I or III antiarrhythmic drug and scheduled for guideline-directed catheter ablation.
Able to understand the study purpose, voluntarily participate, and sign the written informed consent form.
11 exclusion criteria prevent from participating
Presence of advanced structural heart disease.
Life expectancy < 12 months.
Blood pressure < 90/60 mmHg.
Pregnant or lactating women.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Sham

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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