The RESHAPE-HF1-FU Study | NCT02444286

Studies
The RESHAPE-HF1-FU Study

NCT02444286

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Status

Withdrawn

Last Update Posted

Jan 5, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Mitral Valve Insufficiency

Interventions

Not provided

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study did never start, may be deleted from clinicaltrials.gov if possible

Expanded Access Info

Start Date

Jan 2017Estimated

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

May 12, 2015

First Submission Date that Met QC Criteria

May 13, 2015

First Posted Date

May 14, 2015Estimated

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 2, 2024

Last Update Posted Date

Jan 5, 2024Actual

Name	Class
University Medical Center Goettingen	OTHER

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

To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.

Detailed Description

The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard care group		optimal standard of care therapy
device group		Follow-up of MitraClip device implantation plus optimal standard of care therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiovascular (CV) death	Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death	24 months

Secondary Outcomes

Measure	Description	Time Frame
Mitral Regurgitation (MR) severity reduction	Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months	at 12 and 24 months
6 Minute Walk Test (6MWT)	Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Former participant in the RESHAPE-HF Trial (Abbott Vascular)
Subject agrees to return for all required follow-up visits
The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion Criteria:

Withdrawal of Informed Consent
Subject belongs to a vulnerable population

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Goettingen		Göttingen		37075	Germany
University Hospital Mainz

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