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New treatment option for Persistent Atrial Fibrillation
Official title FIH Study of PFLotus in Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT07301190
What this study is testing
- What it's testing
- Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's...
- A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
- Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF. 3\. Poor response...
You likely can't join if
- Paroxysmal atrial fibrillation (AF)
- AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
- Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
- Patients with sustained ventricular tachycardia or ventricular fibrillation
- Left atrial anteroposterior diameter \> 55 mm
- Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation
See the full eligibility 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...
- A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
- 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...
- Paroxysmal atrial fibrillation (AF)
- AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
- Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
- Patients with sustained ventricular tachycardia or ventricular fibrillation
- Left atrial anteroposterior diameter \> 55 mm
- Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation
- History of left atrial ablation or cardiac surgery (including left atrial appendage closure)
- 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)
- Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities
- Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities
- 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
- 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
- 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])
- History of malignant tumor or expected life expectancy \< 12 months
- Mental disorders or history of mental illness with inability to cooperate independently
- Lactating, pregnant, or women planning or potentially becoming pregnant
- Acute or severe systemic infection, or significant abnormalities in liver/renal function
- Participation in other treatment clinical trials, or ineligibility for enrollment as judged by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.