NCT04240366Recruiting
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 29 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 18 Dec 2019
- Start date
- 17 Dec 2019
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- University of Luebeck
- Diseases
- Atrial fibrillation
- NCT number
- NCT04240366
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 17 Dec 2019 to the primary completion date, 30 Jun 2028
- 3 sites 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.
Prior treatment
- Previous pulmonary vein isolation or MAZE surgery
- Previous led atrial appendage closure or surgical excision
Age
- Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years
Other
- Missing informed consent
- LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Left atrial diameter \>60 mm at baseline
- Left atrial thrombus at baseline
Who the study is looking for
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
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 |
|---|---|---|---|
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| University Hospital Eppendorf, Hamburg, Germany Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.