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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00348829
• Other study ID #: SMW 01
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: October 25, 2016
• Start date: June 2006
• Est. completion date: September 2012

Study information

• Verified date: May 2009
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Mitral Insufficiency
• Mitral Valve Insufficiency

Intervention

Procedure:
• mitral valve repair
surgical mitral valve repair

Locations

Country	Name	City	State
Germany	Heart Center Leipzig GmbH, University Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure		3 months	No
Secondary	Identification of clinical factors for the postoperative outcome		3 months	No