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

Primary Purpose

Aortic Stenosis, Mitral Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mitral Valve Clipping
TAVI
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip, Heart Valve Diseases

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart-Center DresdenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

TAVI

TAVI/MitraClip

Arm Description

Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy

Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.

Outcomes

Primary Outcome Measures

Death from any cause and heart failure hospitalization
Composite endpoint of time to heart failure hospitalization or death from any cause

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2019
Last Updated
February 3, 2020
Sponsor
Technische Universität Dresden
Collaborators
KKS Dresden, Zentrum für Klinische Studien Leipzig, University Medical Center Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04009434
Brief Title
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Acronym
MITAVI
Official Title
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
KKS Dresden, Zentrum für Klinische Studien Leipzig, University Medical Center Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Mitral Regurgitation
Keywords
Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip, Heart Valve Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVI
Arm Type
Other
Arm Description
Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
Arm Title
TAVI/MitraClip
Arm Type
Experimental
Arm Description
Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
Intervention Type
Device
Intervention Name(s)
Mitral Valve Clipping
Intervention Description
Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.
Intervention Type
Device
Intervention Name(s)
TAVI
Intervention Description
Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
Primary Outcome Measure Information:
Title
Death from any cause and heart failure hospitalization
Description
Composite endpoint of time to heart failure hospitalization or death from any cause
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death from any cause
Description
Time from randomization to death from any cause
Time Frame
1, 2, 3, 4 years
Title
Need for mitral valve reintervention
Description
Need for mitral valve reintervention
Time Frame
1, 2, 3, 4 years
Title
Mitral regurgitation severity
Description
Mitral regurgitation severity at 12 months
Time Frame
1 year
Title
6 Minute Walk Test
Description
Change in 6 Minute Walk Test at 12 months
Time Frame
1 year
Title
New York Heart Association Functional Class
Description
Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years
Time Frame
1, 3, 6 months and 1, 2, 3, 4 years
Other Pre-specified Outcome Measures:
Title
Number of patients with AEs, SAEs.
Time Frame
1, 2, 3, 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Linke, MD
Phone
+49 351 4501704
Email
mitavi@mailbox.tu-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan Haussig, MD
Phone
+49 351 4501704
Email
mitavi@mailbox.tu-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Linke, MD
Organizational Affiliation
Technische Universitaet Dresden, HEART CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart-Center Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Haussig, MD
Phone
+493514501704

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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