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Comparison of Pericardial Band Annuloplasty and Modified De Vega Technique for Tricuspid Valve Repair: A Randomized Controlled Trial

Comparison of Pericardial Band Annuloplasty and Modified De Vega Technique for Tricuspid Valve Repair: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202604898882603
Enrollment
68
Registered
2026-04-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Tricuspid Valve Repair Cardiology

Interventions

Pericardial Band Annuloplasty
Modified De Vega Technique

Sponsors

Mohamed Elesawy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients presented with left-sided mitral valvular heart disease requiring surgical correction, accompanied by concomitant FTR graded as moderate to severe.

Exclusion criteria

Exclusion criteria: Exclusion criteria were applied to ensure a homogenous study population and minimize confounding variables. Specifically, patients were excluded if they presented with primary tricuspid valve pathology, double valve pathology that required compound surgery or if the regurgitation was graded as only mild to moderate. Furthermore, patients undergoing redo procedures for mitral or aortic valves, those requiring concurrent coronary artery bypass grafting, or individuals with a history of previous tricuspid valve interventions were excluded. Additionally, patients with end-organ dysfunction, and pregnant women were also excluded from the study to ensure the safety of the participants and the reliability of the surgical outcomes.

Design outcomes

Primary

MeasureTime frame
Degree of residual or recurrent tricuspid regurgitation assessed intraoperatively using TEE and postoperatively via TTE within a two-week follow-up period.

Secondary

MeasureTime frame
Secondary outcomes focused on perioperative efficiency and clinical recovery, including operative variables such as total surgical duration, cardiopulmonary bypass time, and aortic cross-clamp time. Additionally, the postoperative clinical course was monitored through the length of stay in the ICU and total hospital duration

Countries

Egypt

Contacts

Public ContactAhmed Soliman

Mansoura University

drahmedsoliman1998@gmail.com001091012731

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026