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

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: Recruiting
• Conditions: Aortic Stenosis; Mitral Regurgitation
• Intervention / Treatment: Device: TAVI; Device: Mitral Valve Clipping

• Study Type: Interventional
• Enrollment (Anticipated): 1162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Axel Linke, MD; Phone Number: +49 351 4501704; Email: mitavi@mailbox.tu-dresden.de
• Study Contact Backup: Name: Stephan Haussig, MD; Phone Number: +49 351 4501704; Email: mitavi@mailbox.tu-dresden.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from any cause	Time from randomization to death from any cause	1, 2, 3, 4 years
Need for mitral valve reintervention	Need for mitral valve reintervention	1, 2, 3, 4 years
Mitral regurgitation severity	Mitral regurgitation severity at 12 months	1 year
6 Minute Walk Test	Change in 6 Minute Walk Test at 12 months	1 year
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	1, 3, 6 months and 1, 2, 3, 4 years

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients with AEs, SAEs.	1, 2, 3, 4 years

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Zentrum für Klinische Studien Leipzig; University Medical Center Mainz; KKS Dresden
• Investigators: Principal Investigator: Axel Linke, MD, Technische Universitaet Dresden, HEART CENTER

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Mitral Regurgitation; MitraClip; Mitral Valve Regurgitation; Heart Valve Diseases; Transcatheter Aortic Valve Implantation; Aortic Disease; Mitral Disease; Mitral valve clipping
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Mitral Valve Insufficiency
• Other Study ID 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