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TerminatedNCT00348829Updated Oct 27, 2016

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

A Phase 2 interventional study of mitral valve repair in Chronic Heart Failure and Mitral Insufficiency, sponsored by University of Leipzig. Terminated at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by University of Leipzig · Phase 2, Interventional, and Diagnostic

Why this study was terminated
not enough patients to e recruited, problems with the conductance catheter
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Chronic Heart Failure
  • Mitral Insufficiency

Keywords

  • CHF
  • mitral insufficiency
  • conductance catheter
  • mitral valve repair
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 5 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    1

    Surgical mitral valve reconstruction

    Procedure: mitral valve repair

  • No intervention
    2

    conservative treatment

Interventions

  • Proceduremitral valve repair

    surgical mitral valve repair

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Identification of clinical factors for the postoperative outcome

    Time frame: 3 months

07

Study locations

1 site
  • Heart Center Leipzig GmbH, University Leipzig
    Leipzig, 04289, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00348829
Lead sponsor
University of Leipzig
Responsible party
Sven Möbius-Winkler (PD Dr. med., University of Leipzig) — Principal investigator
First posted
Jul 6, 2006
Start date
Jun 2006
Primary completion
Dec 2008
Completion
Sep 2012
Last update
Oct 27, 2016

Study contacts

Gerhard Schuler, Prof.
study chair · Chair of the Dep. of Cardiology
Sven Möbius-Winkler, MD
principal investigator · Consultant of the dep. of Cardiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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