Plasty or Prosthesis to Treat Functional Mitral Regurgita... | NCT00947921

Studies
Plasty or Prosthesis to Treat Functional Mitral Regurgitation

NCT00947921

Sponsor

Cardiochirurgia E.H.

Status

Terminated

Last Update Posted

Jan 26, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Functional Mitral Regurgitation

Interventions

Plasty
Prosthesis

Countries

Italy

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 27, 2009

First Posted Date

Jul 28, 2009Estimated

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

Jan 24, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plasty	Active Comparator	Patients treated with restrictive Annuloplasty	Procedure: Plasty
Prosthesis	Active Comparator	Patients treated with valve replacement	Procedure: Prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasty	Procedure	Restrictive Annuloplasty	Plasty
Prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		1 year of follow up after discharge from hospital

Secondary Outcomes

Measure	Description	Time Frame
Freedom from reintervention		1 year of follow-up after discharge from hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients presenting for surgery due to functional mitral regurgitation

Exclusion Criteria:

Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luca Weltert, MD	Cardiochirurgia E.H.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Divisione di Cardiochirurgia, E.H.		Rome		00149	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D019736	Prostheses and Implants

Ancestor Terms

ID	Term
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided