Trial to study efficacy of two surgical procedures for treating atrial fibrillation (abnormal heart rhythm) in patients needing heart valve operation.

Randomized study to assess efficacy of two different ablative procedures to treat atrial fibrillation in patients with rheumatic valvular heart disease.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002162

Enrollment

200

Registered

2011-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Suffering from rheumatic valvular heart disease and atrial fibrillation needing open heart surgery for their valvular disease

Interventions

Intervention1: 1)Biatrial Maze : The surgical procedure involves making ablation of both atria with the use of radiofrequency bipolar coagulation and cryoablation Control Intervention1: Left Atrial M

Eligibility

Inclusion criteria

Inclusion criteria: Patients with chronic atrial fibrillation undergoing valvular heart surgery for rheumatic valvular heart disease, with duration of atrial fibrillation of more than three months, documented by electrocardiogram

Exclusion criteria

Exclusion criteria: Age less than 12 years and more than 60 years Pregnancy Left atrial size more than six centimetres Previous median sternotomy Coronary artery disease needing surgical coronary bypass

Design outcomes

Primary

Measure	Time frame
Conversion to sinus rhythmTimepoint: Conversion to sinus rhythm at six months after intervention.	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr A M Patwardhan

Jawaharlal Nehru Medical College

anil.patwardhan@gmail.com9322512223

Outcome results

None listed

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