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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348829

Enrollment

Registered

2006-07-06

Start date

2006-06-30

Completion date

2012-09-30

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Mitral Insufficiency

Keywords

CHF, mitral insufficiency, conductance catheter, mitral valve repair

Brief 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.

Interventions

PROCEDUREmitral valve repair

surgical mitral valve repair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure	3 months

Secondary

Measure	Time frame
Identification of clinical factors for the postoperative outcome	3 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026