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NCT06156644Not yet recruiting

Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator

Source: ClinicalTrials.gov · Last updated 3 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
13 Nov 2023
Start date
1 Jul 2025
Primary completion date
1 Dec 2025
Lead sponsor
University Hospital Freiburg
NCT number
NCT06156644

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Jul 2025 to the primary completion date, 1 Dec 2025
  • No sites listed in no 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.

Prior treatment

  • previous left atrial ablation
  • unable to receive ablation therapy

Age

  • age \<18 years

Other

  • lack or withdrawal of written informed consent

Who the study is looking for

  • new onset atrial fibrillation

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.