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NCT06383975Recruiting

VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF

Comparison Between VEin of MArshall Ethanol Infusion Versus Extended Pulmonary Vein PULSEd Field Ablation After Failed Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 9 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat. The main question the trial aims to answer is: • Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure? Participants will: * Undergo an ablation with either the new or the standard technique * Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up * Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit * Record their heart rhythm at home every week * Complete a questionnaire 3, 6, 9 and 12 months after the procedure

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
16 Apr 2024
Start date
15 May 2024
Primary completion date
30 Apr 2027
Lead sponsor
Sebastien Knecht
NCT number
NCT06383975

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 15 May 2024 to the primary completion date, 30 Apr 2027
  • 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.

Other illness

  • Advanced valvular heart disease

Other

  • Persistent AF lasting ≥ 12 months
  • Left atrial (LA) volume \>150mL
  • LA diameter (PS-LAX) \>60mm
  • Septal wall diameter \>15mm
  • Life expectancy \<1 year
  • Weight \>150 kg
  • Any contra indication to catheter ablation

Who the study is looking for

  • Symptomatic persistent atrial fibrillation (AF) despite a first PVI. Persistent AF is defined as the presence of AF lasting ≥7 days (i.e. in case of new onset AF one has to wait for 7 days)

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Az Sint-Jan Brugge Av
Coordinator of this site? Confirm its status
BrugesBelgiumRecruiting

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