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

NCT00348829 | Terminated Phase 2

• 1 other identifier: SMW 01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Chronic Heart Failure; Mitral Insufficiency

Keywords

CHF; mitral insufficiency; conductance catheter; mitral valve repair

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• Identification of clinical factors for the postoperative outcome

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Surgical mitral valve reconstruction

Procedure: mitral valve repair

2

NO INTERVENTION

conservative treatment

Interventions

mitral valve repair PROCEDURE

surgical mitral valve repair

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Heart Center Leipzig GmbH, University Leipzig

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Gerhard Schuler, Prof.

  Chair of the Dep. of Cardiology

  STUDY CHAIR

• Sven Möbius-Winkler, MD

  Consultant of the dep. of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: September 1, 2012
• Last Updated: October 27, 2016

Record last verified: 2009-05

Locations

DE (1)