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The effectiveness of Maze surgical ablation using different mechanism radiofrequency devices during heart valve surgery: a randomized controlled clinical study

The effectiveness of Maze surgical ablation using different mechanism radiofrequency devices during heart valve surgery: a randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042579
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-02-20
Completion date
Unknown
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

AtriCure non-irrigation bipolar radio frequency group:AtriCure bipolar radio frequency machine
Medtronic irrigation bipolar radio frequency group:Medtronic irrigation bipolar radio frequency machine
AtriCure non-irrigation bipolar radio frequency combination device group:AtriCure bipolar radio frequency pen and clamp

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 8-80 years, no gender limit; 2. Heart valve surgery combined with persistent or long-term persistent atrial fibrillation is required; 3. Sign an informed consent form before performing any inspection or operation specified in the plan; 4. Able and willing to comply with all The preliminary and follow-up review and requirements.

Exclusion criteria

Exclusion criteria: 1. Past atrial fibrillation surgery or catheter ablation (excluding atrial flutter or other supraventricular arrhythmia ablation); 2. The mental and/or physical cannot adapt to the follow-up period; 3. Arrhythmia secondary to reversible or non-cardiac causes; 4. Patients with cardiomyopathy, coronary heart disease or New York heart function classification III-IV or severe cardiac insufficiency with left ventricular ejection fraction 80 U/l, aspartate aminotransferase [AST] > 80 U/l, creatinine > 132 mol/l); 6. Women of childbearing age and lactation who have a positive pregnancy test or who have not taken contraceptive measures; 7. Patients with immune system diseases such as malignant tumors, rheumatic connective tissue; 8. Life expectancy is within 24 months; 9. Patients who are contraindicated in the use of anticoagulants.

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation recurrence 6 months after surgery;

Secondary

MeasureTime frame
Recurrence of atrial fibrillation at 1 and 3 months after surgery;Postoperative recurrence of atrial fibrillation (three-dimensional electro-anatomical mapping);Any surgery-related complications;Major cardiovascular events;

Countries

China

Contacts

Public ContactZhan Peng

Beijing Anzhen Hospital, Capital Medical University

anzhen0607@126.com+86 19801117307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026