NCT07320976Active, not recruiting
FIH of PFBalloon for PVI
First-in-Human Study of a Novel Conformal Pulsed-Field Ablation Balloon Catheter for Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
The goal of this clinical trial is to assess the safety and effectiveness of a conformal pulsed field ablation (PFA) balloon catheter for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). It will also explore the durable effectiveness of this novel catheter through post-ablation remapping. The main questions it aims to answer are: Does the conformal PFA balloon catheter achieve absence of periprocedural primary adverse events (primary safety endpoint)? Does the conformal PFA balloon catheter achieve acute PVI (primary effectiveness endpoint) and durable PVI at three months post-ablation (secondary effectiveness endpoint)? This is a first-in-human, single-center trial that employs a novel PFA balloon catheter with a biphasic, bipolar 750 V waveform. The balloon is inflated with a 10:1 saline/contrast mixture, with deployment volume adjusted to form a sphere shape for wide-antral PV ablation or a pear shape for targeted ostial-junction ablation to ensure optimal tissue contact. Participants will: Undergo PVI using the novel conformal PFA balloon catheter; Be monitored for periprocedural primary adverse events to assess safety; Undergo remapping at three months post-ablation to assess durable PVI; Undergo follow-up visits scheduled for seven-days, 30-days, three-months, six-months, and 12-months post-procedure. Recurrence assessment includes: 1) routine 12-lead ECG examination during each visit and 2) 24-hour or seven-day Holter monitoring at six and 12 months.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 8 Dec 2025
- Start date
- 10 Jul 2024
- Primary completion date
- 18 Feb 2025
- Lead sponsor
- The Third People's Hospital of Chengdu
- Diseases
- Atrial fibrillation
- NCT number
- NCT07320976
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 10 Jul 2024 to the primary completion date, 18 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 1\. Inclusion Criteria:
- Aged 18-75 years
- Documented symptomatic paroxysmal atrial fibrillation with episode duration \<7 days
- Refractory or intolerant to at least one Class I or III antiarrhythmic drug
- 2\. Exclusion Criteria:
- Atrial fibrillation caused by reversible or non-cardiac factors
- Prior AF ablation or cardiac surgery history
- Anticipated need for extra-pulmonary vein isolation (extra-PVI) ablation
- Persistent atrial fibrillation
- Left atrial diameter \>50 mm
- Left ventricular ejection fraction \<40%
- Presence of an implantable cardiac device (e.g., pacemaker, implantable cardioverter-defibrillator)
- Intracardiac thrombus
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.