Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation

Last updated: April 8, 2024
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

Posterior wall isolation

VOMEI + PVI + linear ablation of mitral isthmus

Clinical Study ID

NCT06363604
XHEC-C-2023-128-2
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 18-85 years old;
  2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
  3. Prepared to undergo atrial fibrillation catheter ablation;
  4. Provide informed consent to participate in the study, comply with follow-up trials andevaluation procedures.

Exclusion

Exclusion Criteria:

  1. Presence of acute conditions such as acute phase after myocardial infarction (within 3months), acute heart failure or new onset of cerebral infarction within 3 months;
  2. On the heart transplant list;
  3. Life expectancy less than 1 year;
  4. With other bleeding disorders that cannot be treated with anticoagulation therapy;
  5. With left atrial thrombus;
  6. Heart failure with NYHA class III-IV or LVEF<40%;
  7. With uncontrolled malignant tumor;
  8. Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limitof normal, and/or CCr<50%);
  9. History of catheter radiofrequency ablation for atrial fibrillation or cardiacsurgery;
  10. Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearingage but not using reliable contraception.

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Posterior wall isolation
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
November 30, 2026

Study Description

A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.

Group 1: VOMEI + PVI + linear ablation + PWI; Group 2: VOMEI + PVI +linear ablation. The major endpoint (efficacy endpoint) is the recurrence of atrial tachyarrhythmias between 3-12 months during follow-up. The secondary endpoint (safety endpoint) is the occurrence of procedural complications.

Connect with a study center

  • Xinhua Hospital, Shanghai Jiao Tong University

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

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