NCT06363604Recruiting
Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation
Randomized Controlled Study of Atrial Posterior Wall Isolation (PWI) Assisted by Vein of Marshall Ethanol Infusion (VOMEI) and Pulmonary Vein Isolation in Persistent Atrial Fibrillation Ablation
Source: ClinicalTrials.gov · Last updated 12 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 21 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Atrial fibrillation
- NCT number
- NCT06363604
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 1 Dec 2023 to the primary completion date, 30 Sept 2026
- 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.
Prior treatment
- With other bleeding disorders that cannot be treated with anticoagulation therapy;
Other illness
- Presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months;
- On the heart transplant list;
- With uncontrolled malignant tumor;
- History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
Lab values
- Heart failure with NYHA class III-IV or LVEF\<40%;
- Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%);
Age
- Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.
Other
- Life expectancy less than 1 year;
- With left atrial thrombus;
Who the study is looking for
- Between 18-85 years old;
- Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
- Prepared to undergo atrial fibrillation catheter ablation;
- Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.