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

Phase 2TerminatedNCT00348829

University of Leipzig5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Chronic Heart Failure Mitral Insufficiency

Interventions

mitral valve repairPROCEDURE

surgical mitral valve repair

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart Center Leipzig GmbH, University Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure

Time frame: 3 months

Secondary Outcomes

Identification of clinical factors for the postoperative outcome

Time frame: 3 months

Data from ClinicalTrials.gov

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