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A prospective trial of cut-and-sew Cox maze III procedure versus cryosurgical Cox-Maze procedure for atrial fibrillation associated with heart valve disease

A prospective trial of cut-and-sew Cox maze III procedure versus cryosurgical Cox-Maze procedure for atrial fibrillation associated with heart valve disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008112
Enrollment
Unknown
Registered
2016-03-17
Start date
2016-03-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

atrial fibrillation

Interventions

Maze III group:cut-and-sew Cox maze procedure and mitral valve surgery
cryoablation group:cryoablation and mitral surgery

Sponsors

General Hospital of Shenyang Millitary Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Clinical indications for heart valve surgery to choose one of the following: valvular surgery over the same period maze procedure. Mainly perform mitral valve surgery, combine functional tricuspid valve surgery, aortic valve surgery, coronary artery bypass grafting (CABG), or repair of atrial septal defects (such as in the same period operation, if necessary.

Exclusion criteria

Exclusion criteria: 1. Secondary or multiple heart surgeries; 2. Accompanied by other surgery for other parts of the body; 3. Liver and kidney dysfunction (test results exceed 3 times the upper limit of normal); 4. Require radiotherapy, chemotherapy, or long-term hormone therapy; 5. Mental impairment that may not understand the study; 6. Enrollent in other clinical trials; 7. Pure ischemic mitral regurgitation.

Design outcomes

Primary

MeasureTime frame
Freedom from atrial fibrillation;y death;Early stroke;Heart failure;Cardiac re-hospitalization;Requiring permanent pacemaker;Bleeding;arrhythmias;ICU;Hospital stay;NYHA cardiac class;Hepatic dysfunction;Kindey dysfunction;Ventilator time;

Secondary

MeasureTime frame
Need for electrical cardioversion;Use of anti-arrhythmic drugs;All-cause death;Echocardiography index;

Countries

China

Contacts

Public ContactWang huishan

General Hospital of Shenyang Millitary Command

huishanwang@hotmail.com+86 02428897381

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026