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Double procedure may keep AFib away longer

NCT ID NCT07320768

Disease control Sponsor: Shanghai Chest Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a nerve-calming kidney procedure (renal denervation) to standard heart ablation (pulsed-field ablation) can better prevent atrial fibrillation from coming back. About 86 adults with persistent AFib will be randomly assigned to get either the combination or ablation alone. The main goal is to see if the combo keeps the heart in normal rhythm for at least 12 months without needing antiarrhythmic drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
renal denervation and pulsed-field ablation (both catheter-based procedures)
What this could lead to
If successful, this combination procedure could reduce the chance of atrial fibrillation coming back after ablation, potentially decreasing the need for repeat procedures or long-term medication.
What could go wrong
This is a small, early-stage trial (86 participants) and results may not apply to everyone. The procedures carry risks like bleeding, blood vessel damage, or heart rhythm issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Presence of advanced structural heart disease. * Life expectancy \< 12 months. * Blood pressure \< 90/60 mmHg. * Pregnant or lactating women. * Anatomical abnormalities of the renal arteries unsuitable for treatment as determined by pre-procedural renal CTA. * History of renal artery intervention, impaired renal function with estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m² (calculated by the MDRD equation). * Secondary atrial fibrillation due to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes. * Contraindication to pulsed-field ablation (e.g., left atrial thrombus, prior atrial septal defect occluder implantation, or permanent metallic implant in the left atrium) or to anticoagulation therapy. * Known inability to obtain vascular access or contraindication to femoral venous puncture. * Heart failure with left ventricular ejection fraction \< 30% documented by transthoracic echocardiography within 3 months before ablation. * Patients with current or anticipated need for pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT), or prior transseptal closure with occluder device for atrial septal defect or patent foramen ovale.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent atrial fibrillation

Contacts and locations

Locations

  • Shanghai Chest Hospital

    Shanghai, 200030, China

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