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

Aortic Stenosis Clinical Trial

— MITAVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009434
• Other study ID #: MITAVI
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2020
• Source: Technische Universität Dresden
• Contact: Axel Linke, MD
• Phone: +49 351 4501704
• Email: mitavi[@]mailbox.tu-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1162
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Heart-Center Dresden	Dresden	Saxony

Sponsors (4)

Lead Sponsor	Collaborator
Technische Universität Dresden	KKS Dresden, University Medical Center Mainz, Zentrum für Klinische Studien Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with AEs, SAEs.		1, 2, 3, 4 years
Primary	Death from any cause and heart failure hospitalization	Composite endpoint of time to heart failure hospitalization or death from any cause	1 year
Secondary	Death from any cause	Time from randomization to death from any cause	1, 2, 3, 4 years
Secondary	Need for mitral valve reintervention	Need for mitral valve reintervention	1, 2, 3, 4 years
Secondary	Mitral regurgitation severity	Mitral regurgitation severity at 12 months	1 year
Secondary	6 Minute Walk Test	Change in 6 Minute Walk Test at 12 months	1 year
Secondary	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