Shape-Shifting catheter takes on stubborn heart rhythm disorder
NCT ID NCT07301190
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new catheter that changes shape to better treat persistent atrial fibrillation (AF), a type of irregular heartbeat. The catheter can switch between a large 'petal' shape for quick vein isolation and a small 'bud' shape for precise linear ablation. Forty adults with persistent AF will undergo the procedure and be monitored for a year to see if it's safe and creates lasting effects.
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 (pulsed field ablation device)
- What this could lead to
- If it works, this could offer a more flexible and effective way to treat persistent atrial fibrillation with a single device.
- What could go wrong
- This is a very early, small trial with only 40 people. It's designed mainly to check safety and short-term results, not to prove long-term benefit. The procedure carries risks like bleeding, heart damage, or stroke.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Apr 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 Hide 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 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Persistent atrial fibrillation are added.
Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The Third People's Hospital of Chengdu
RECRUITINGChengdu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?
- Can a diabetes drug keep the heart in rhythm?