A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation (Reshape-HF2)

July 2, 2024 updated by: Karsten Gavenis, University Medical Center Goettingen

Randomised Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients With Clinically Significant Functional Mitral Regurgitation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
505

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 14021
        • Klinika Kardiologie IKEM
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet Copenhagen
      • Odense, Denmark
        • OUH Odense
  • Germany
      • Berlin, Germany, 12200
        • Charité
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Genthin, Germany, 39576
        • Johanniter Krankenhaus
      • Göttingen, Germany, 37075
        • University Medical Center Goettingen
      • Halle, Germany, 06097
        • Universitatsklinikum Halle
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Jena, Germany, 07747
        • Universitatsklinikum Jena
      • Mainz, Germany, 55131
        • University Hospital Mainz
      • Würzburg, Germany, 97080
        • Universitätsklinik Würzburg
  • Greece
      • Athens, Greece
        • HYGEIA Hospital Athens
      • Thessaloníki, Greece, 57001
        • Interbalkan Medical Center
      • Thessaloníki, Greece
        • St. Luke's Hospital Thessaloniki
  • Italy
      • Brescia, Italy
        • AOC Brescia
  • Poland
      • Katowice, Poland, 40-635
        • Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawła II
      • Poznań, Poland, 61-848
        • Poznan Medical University
      • Wrocław, Poland, 50981
        • Medical University Department of Heart Diseases
      • Zabrze, Poland, 41-800
        • Slaskie Centrum Chorob Serca
  • Portugal
      • Lisbon, Portugal, 1169-1024
        • Lisbon St. Marta Hospital
      • Lisbon, Portugal
        • Lisbon St. Maria Hospital
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar Vila Nova de Gaia / Espinho
  • Spain
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Leon, Spain
        • HUL Leon
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Valladolid, Spain
        • Instituto de Ciencias del Corazón (ICICOR)
  • United Kingdom
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • Hull, United Kingdom
        • Castle Hill Hospital
      • London, United Kingdom
        • The Royal Brompton and Harefield Hospitals
      • Manchester, United Kingdom
        • Wythenshawe Hospital of South Manchester - Manchester University NHS Foundation Trust (MFT)
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke Hospital - University Hospital of North Midlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
  • Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
  • Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Ambulatory patient with symptomatic congestive heart failure (CHF) in NYHA functional class II to IV (despite optimal standard of care therapy as assessed within 30 days preceding randomization) and with LVEF 20% to 50%. Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization
  • Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness

Key Exclusion Criteria:

  • Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
  • Status 1 heart transplant or prior orthotropic heart transplantation.
  • Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
  • Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Note:Acute coronary syndrome (ACS) is defined as an ACS that requires an intervention. Increased troponin without acute symptoms and chest pain is not defined as ACS.
  • Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
  • Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization.
  • Need for any cardiovascular surgery.
  • Mitral valve surgery is considered the preferred therapeutic option for the subject
  • Renal replacement therapy
  • 6-Minute Walk Test (6MWT) distance > 475 meters
  • Mitral Valve Area (MVA) by planimetry < 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
optimal standard of care therapy
Other: standard of care
Experimental: Device Group
MitraClip device plus optimal standard of care therapy
Other: standard of care
Device: MitraClip
Implantation of the MitraClip System for patients with chronic heart failure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
Time Frame: 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months
24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
Time Frame: 24 months
Rate of total (first and recurrent) HF hospitalizations within 24 months
24 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
Time Frame: 12 months
Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory
Time Frame: at 12 months
Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory
at 12 months
Change in 6 Minute Walking Test distance from baseline to 12 months
Time Frame: from baseline to 12 months
Change in 6 Minute Walking Test distance from baseline to 12 months
from baseline to 12 months
All-cause mortality during all available follow-up
Time Frame: during all available follow-up
All-cause mortality during all available follow-up
during all available follow-up
Rate of total (first and recurrent) hospitalizations for any cause within 24 months
Time Frame: 24 months
Rate of total (first and recurrent) hospitalizations for any cause within 24 months
24 months
Percentage of patients in NYHA function class I/II at 12 months
Time Frame: 12 months
Percentage of patients in NYHA function class I/II at 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Goettingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Medical Center Goettingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang Schillinger, Prof., University Medical Center Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Version No. 6.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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