Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy

University of Leipzig1 site in 1 country5 target enrollmentJune 2006

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Heart Failure
Sponsor: University of Leipzig
Enrollment: 5
Locations: 1
Primary Endpoint: Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
Status: Terminated
Last Updated: 9 years ago

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

Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

September 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

University of Leipzig

Responsible Party

Principal Investigator

Sven Möbius-Winkler

PD Dr. med.

University of Leipzig

•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

•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