NCT06845085Not yet recruiting
Re-ablation of Persistent Atrial Fibrillation
Re-ablation of Persistent Atrial Fibrillation: a Randomized Study, Evaluating Vein of Marshall Ethanol Ablation in Combination With Block of Mitral and Tricuspid Isthmuses and Dome Line
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line will be compared to pulmonary vein re-isolation alone in patients undergoing re-ablation for persistent atrial fibrillation in this investigator initiated, randomized, patient-assessor blinded multicenter trial. Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation. Primary endpoint: Change in AFEQT score between baseline and 12 months.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- Mar 2025
- Primary completion date
- Oct 2029
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06845085
What you commit to
- Study type: Interventional
- Planned participants: 180
- From Mar 2025 to the primary completion date, Oct 2029
- 3 sites in 3 countries
- 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 extrapulmonary atrial ablation other than cavotricuspid isthmus line, roof- or dome line or posterior wall isolation/ablation
Other illness
- Uncontrolled hypertension
- Acute coronary syndrome, cardiac surgery, or TIA/stroke within the last 3 months
- Planned cardiac surgery within 1 year
- Dialysis or severe renal failure
Other
- Atypical atrial flutter in addition to atrial fibrillation
- Atrial fibrillation secondary to a transient abnormality
- Active substance or alcohol abuse (\>14 units/week)
Who the study is looking for
- Previous pulmonary vein isolation for atrial fibrillation
- Indication for catheter ablation with at least two episodes of symptomatic PsAF during the last 12 months
- Age \> 18 years
- Expected survival \> 12 months
- Able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Aarhus University Hospital Coordinator of this site? Confirm its status | Århus N | Denmark | Unknown status |
| Department of Cardiology, Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Department of Cardiology, Karolinska University Hospital, Stockholm Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.