RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Radiofrequency/Pulsed Field Ablation for Atrial Fibrillation

This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).

Official registry: https://clinicaltrials.gov/study/NCT07845682 · Biosense Webster, Inc. · enrollment listed as 150

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Radiofrequency/Pulsed Field Ablation. The registry lists allocation as na. This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).

They plan to enroll about 150 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)

Interventions: Radiofrequency/Pulsed Field Ablation

Primary outcome (registry wording): Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD
Willing and capable of providing consent

Who the registry excludes

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
Documented severe dilatation of the left atrium (LA) (LAD \>50 millimetre \[mm\]) antero-posterior diameter on imaging within 6 months prior to procedure
Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to procedure
Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume \>=60 millilitre (mL)/beat, Regurgitant fraction \>=50%, and/or effective regurgitant orifice area \>=0.40 square centimetre (cm\^2)
Moderate-severe, severe tricuspid valve regurgitation or insufficiency
Documented LA thrombus by imaging within 48 hours of the procedure or by intracardiac echocardiography (ICE) prior to transeptal puncture during procedure
Previous LA ablation or surgery

Public study contact (from the registry)

Yun Bai

+86 15810492554

ybai8@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

Beijing Anzhen Hospital, Capital Medical University — Beijing, China (recruiting)
Qilu Hospital of Shandong University — Jinan, China (recruiting)
Jiangsu Province Hospital — Nanjing, China (recruiting)
Shanghai Chest Hospital — Shanghai, China (recruiting)

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FAQ about this NCT record

Is NCT07845682 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07845682?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07845682?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary