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New catheter aims to tame stubborn AFib

NCT ID NCT07321002

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new shape-adaptive catheter that uses pulsed field ablation to treat persistent atrial fibrillation (AFib), a type of irregular heartbeat. 35 adults with persistent AFib will receive the procedure under general anesthesia. Researchers will check for serious side effects within 7 days and see if the treatment successfully restores normal heart rhythm.

What this could mean

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

Active substance
PFLotus catheter and DePolar mapping system
What this could lead to
If successful, this could provide a safer and more effective way to treat persistent atrial fibrillation using a single catheter system.
What could go wrong
This is a small, early-stage trial with only 35 participants. The procedure carries risks like bleeding, heart damage, or irregular heartbeat. Results may not apply to all patients.

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 35 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jul 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 to 75 years

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: 1\. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment: 1. A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period. 2. Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF. 3\. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD). 4\. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written informed consent. Exclusion Criteria: 1. Paroxysmal atrial fibrillation (AF); 2. AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies; 3. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias; 4. Patients with sustained ventricular tachycardia or ventricular fibrillation; 5. Left atrial anteroposterior diameter \> 55 mm; 6. Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation; 7. History of left atrial ablation or cardiac surgery (including left atrial appendage closure); 8. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function); 9. Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities; 10. Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities; 11. Any of the following cardiac surgeries, implants, or conditions: * Prosthetic heart valve * NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 40% * Atrial septal defect or ventricular septal defect closure * Atrial myxoma, left atrial appendage device implantation or occlusion 12. History of any of the following within 3 months prior to the procedure: * Myocardial infarction * Unstable angina * Percutaneous coronary intervention * Cardiac surgery (including coronary artery bypass grafting) * Hospitalization for heart failure * Pericarditis 13. History of any of the following within 3 months prior to the procedure: * Cerebral infarction or transient ischemic attack (TIA) * Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \[TEE\]) 14. History of malignant tumor or expected life expectancy \< 12 months; 15. Mental disorders or history of mental illness with inability to cooperate independently; 16. Lactating, pregnant, or women planning or potentially becoming pregnant; 17. Acute or severe systemic infection, or significant abnormalities in liver/renal function; 18. Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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More trials for these conditions

Other studies related to the condition(s) this trial covers.