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

University of Leipzig

Status and phase: Terminated; Phase 2

Conditions: Chronic Heart Failure; Mitral Insufficiency

Treatments: Procedure: mitral valve repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00348829

SMW 01

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

1

Active Comparator group

Description:

Surgical mitral valve reconstruction

Treatment:

Procedure: mitral valve repair

2

No Intervention group

Description:

conservative treatment