Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy

Phase 2

Terminated

• Conditions: Mitral Insufficiency; Chronic Heart Failure
• Interventions: Procedure: mitral valve repair

• Registration Number: NCT00348829
• Lead Sponsor: University of Leipzig

Brief Summary

The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.

1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.

2. Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Primary Completion: 2008-12
• Status Verified: 2009-05
• Study Completion: 2012-09
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Age > 18 years old
2. Dilatative Cardiomyopathy with LVEF < 35%
3. NYHA III oder IV under maximal medical treatment
4. Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)
5. Echocardiographic MI > II°
6. At least 1 hospitalization for heart failure before OP

Exclusion Criteria

1. Secondary Cardiomyopathy by vitium cordis
2. Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
3. Inclusion in another trial
4. Euro-Score > 30%
5. Former valve operation or CABG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mitral valve repair	Surgical mitral valve reconstruction

Primary Outcome Measures

Name	Time	Method
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure	3 months

Secondary Outcome Measures

Name	Time	Method
Identification of clinical factors for the postoperative outcome	3 months

Trial Locations

Locations (1)

Heart Center Leipzig GmbH, University Leipzig; 🇩🇪 Leipzig, Germany