Mitral Valve Reconstruction in Chronic Heart Failure (CHF... | NCT00348829

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

NCT00348829

Sponsor

University of Leipzig

Status

Terminated

Last Update Posted

Oct 27, 2016Estimated

Enrollment

5Actual

Phase

Phase 2

Conditions

Chronic Heart Failure
Mitral Insufficiency

Interventions

mitral valve repair

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough patients to e recruited, problems with the conductance catheter

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Surgical mitral valve reconstruction	Procedure: mitral valve repair
2	No Intervention	conservative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral valve repair	Procedure	surgical mitral valve repair	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerhard Schuler, Prof.	Chair of the Dep. of Cardiology	Study Chair
Sven Möbius-Winkler, MD	Consultant of the dep. of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Leipzig GmbH, University Leipzig		Leipzig		04289	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058386	Mitral Valve Annuloplasty

Ancestor Terms

ID	Term
D058385	Cardiac Valve Annuloplasty
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided