TerminatedPhase 2

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

Stopped: not enough patients to e recruited, problems with the conductance catheter

Germany5 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT00348829

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

View on ClinicalTrials.gov More Chronic Heart Failure trials