Ablation Strategies for Persistent Atrial Fibrillation Combined With Heart Failure
Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure
1 other identifier
interventional
130
1 country
1
Brief Summary
(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jun 2022
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2022
CompletedFirst Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2025
CompletedJune 3, 2024
May 1, 2024
3 years
January 2, 2024
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative recurrence rate
Postoperative recurrence rate was evaluated by holter monitoring.
12 months after operation
Study Arms (2)
2C3L group
SHAM COMPARATORAblation Procedure：2C3L
2C3L-plus group
EXPERIMENTALAblation Procedure：2C3L combined with Marshall ethanol ablation
Interventions
Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation，anhydrous alcohol ablation of VOM
Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation
Eligibility Criteria
You may qualify if:
- age:18y-80y
- First ablation on non valvular atrial fibrillation
- Persistent atrial fibrillation with LVEF≤40%
- The patient has symptoms related to atrial fibrillation, including but not limited to palpitations, premonitory syncope, syncope, fatigue, and shortness of breath, and is evaluated for clinical cardiac function between NYHA II-IV levels
- No response to antiarrhythmic drugs, unacceptable side effects, or unwillingness to take antiarrhythmic drugs.
You may not qualify if:
- Paroxysmal atrial fibrillation
- Atrial fibrillation secondary to obvious reversible causes
- Echocardiography: Parasternal long axis section, left atrial diameter ≥ 60mm
- LVEF \>40%
- Receiving dual antithrombotic therapy
- Contraindications to the use of oral anticoagulants
- Contraindications to right or left cardiac catheterization
- pregnancy
- Life expectancy\<1 year (such as advanced malignant tumors, advanced kidney disease, etc.)
- Unable to discontinue antiarrhythmic drugs due to reasons other than atrial fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hesheng Hu
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hesheng Hu
Shandong First Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
June 3, 2024
Study Start
June 16, 2022
Primary Completion
June 16, 2025
Study Completion
June 16, 2025
Last Updated
June 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share