PFLotus shape-adaptive pulsed-field catheter for persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PFLotus catheter can switch between a large 'petal' configuration for single‑shot pulmonary vein isolation and a small spherical 'bud' for focal or linear ablation, enabling a PVI‑plus strategy. Patients with persistent AF undergo PVI and additional linear lesions under general anesthesia using bipolar, biphasic pulsed‑field energy (850 V, 60 μs). The primary safety endpoint is absence of serious procedure- or device-related adverse events within 7 days, and durability of lesions is tested by remapping within three months after the index procedure. Enrollment required documented persistent AF and prior failure or intolerance of at least one class I or III antiarrhythmic drug, and all procedures were performed at the lead site in Chengdu.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets \*\*any one\*\* of the following criteria:

1. A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
2. Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.

3\. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs.

4\. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.

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

Where it's running

• The Third People's Hospital of Chengdu
  Chengdu, China Recruiting

Study contacts

• Study coordinator: Shiqiang Xiong, Doctor of Medicine
• Email: xionglliu@163.com
• Phone: 8619980510703

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

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  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

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• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

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• Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

  This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.

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• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

  This study tests whether adding posterior wall isolation and superior vena cava isolation to pulmonary vein isolation with pulsed-field ablation helps people with persistent atrial fibrillation stay in rhythm.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07405359

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.