Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation. (MITAVI)

February 3, 2020 updated by: Technische Universität Dresden

Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
1162

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

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Heart-Center Dresden
        • Contact:
          • Stephan Haussig, MD
          • Phone Number: +493514501704

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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
  • Moderate to severe mitral regurgitation
  • Symptom status NYHA II-III
  • Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
  • Age ≥ 18 and < 90 years
  • Written informed consent

Exclusion criteria

  • MR mechanism/anatomy precluding MitraClip therapy
  • Groin blood vessels are not eligible for TAVI procedure
  • Massive or torrential tricuspid regurgitation
  • Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
  • Life expectancy < 1 year due to non-cardiac conditions
  • LVEF ≤ 25%
  • Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
  • Cardiomyopathy other than dilated cardiomyopathy
  • Fixed pulmonary artery systolic pressure > 70 mm Hg
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Stroke or transient ischemic event within 6 months prior to randomization
  • Severe symptomatic carotid stenosis
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
  • Need for any other cardiovascular surgery (other than MV or AV disease)
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Active endocarditis or active infections requiring current antibiotic treatment
  • Any condition making it unlikely that the patient will be able to complete all protocol procedures
  • Patient unable to provide written informed consent prior to study enrolment
  • Pregnant or nursing women
  • Women of child bearing potential
  • Current participation in any other interventional clinical trial
  • Patients under legal supervision or guardianship Patients placed in an institution by official or court order

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: None (Open Label)

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.
Other: TAVI
Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
Device: TAVI
Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
Experimental: TAVI/MitraClip
Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
Device: TAVI
Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
Device: Mitral Valve Clipping
Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.

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
Death from any cause and heart failure hospitalization
Time Frame: 1 year
Composite endpoint of time to heart failure hospitalization or death from any cause
1 year

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
Death from any cause
Time Frame: 1, 2, 3, 4 years
Time from randomization to death from any cause
1, 2, 3, 4 years
Need for mitral valve reintervention
Time Frame: 1, 2, 3, 4 years
Need for mitral valve reintervention
1, 2, 3, 4 years
Mitral regurgitation severity
Time Frame: 1 year
Mitral regurgitation severity at 12 months
1 year
6 Minute Walk Test
Time Frame: 1 year
Change in 6 Minute Walk Test at 12 months
1 year
New York Heart Association Functional Class
Time Frame: 1, 3, 6 months and 1, 2, 3, 4 years
Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years
1, 3, 6 months and 1, 2, 3, 4 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of patients with AEs, SAEs.
Time Frame: 1, 2, 3, 4 years
1, 2, 3, 4 years

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.
Technische Universität Dresden

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.
Zentrum für Klinische Studien Leipzig
University Medical Center Mainz
KKS Dresden

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: Axel Linke, MD, Technische Universitaet Dresden, HEART CENTER

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 (Actual)

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.
December 1, 2019

Primary Completion (Anticipated)

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.
August 1, 2023

Study Completion (Anticipated)

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.
August 1, 2023

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).
July 3, 2019

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.
July 3, 2019

First Posted (Actual)

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.
July 5, 2019

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.
February 5, 2020

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.
February 3, 2020

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.
February 1, 2020

More Information

Terms related to this study

Keywords

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.
  • MITAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within five years, if the members of the MITAVI-trial group agree.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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