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出境医 / 临床实验 / 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. (MITAVI)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Stenosis Mitral Regurgitation | Device: Mitral Valve Clipping Device: TAVI | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1162 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation |
| Actual Study Start Date : | December 1, 2019 |
| Estimated Primary Completion Date : | August 1, 2023 |
| Estimated Study Completion Date : | August 1, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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.
|
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Experimental: TAVI/MitraClip
Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
|
Device: Mitral Valve Clipping
Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.
Device: TAVI Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Death from any cause [ Time Frame: 1, 2, 3, 4 years ]Time from randomization to death from any cause
- Need for mitral valve reintervention [ Time Frame: 1, 2, 3, 4 years ]Need for mitral valve reintervention
- Mitral regurgitation severity [ Time Frame: 1 year ]Mitral regurgitation severity at 12 months
- 6 Minute Walk Test [ Time Frame: 1 year ]Change in 6 Minute Walk Test at 12 months
- 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
Other Outcome Measures:
- Number of patients with AEs, SAEs. [ Time Frame: 1, 2, 3, 4 years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Axel Linke, MD | +49 351 4501704 | mitavi@mailbox.tu-dresden.de | |
| Contact: Stephan Haussig, MD | +49 351 4501704 | mitavi@mailbox.tu-dresden.de |
Locations
| Germany | |
| Heart-Center Dresden | Recruiting |
| Dresden, Saxony, Germany, 01307 | |
| Contact: Stephan Haussig, MD +493514501704 | |
Sponsors and Collaborators
Technische Universität Dresden
KKS Dresden
Zentrum für Klinische Studien Leipzig
University Medical Center Mainz
Investigators
| Principal Investigator: | Axel Linke, MD | Technische Universitaet Dresden, HEART CENTER |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 3, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | February 5, 2020 | ||||||||
| Actual Study Start Date ICMJE | December 1, 2019 | ||||||||
| Estimated Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Number of patients with AEs, SAEs. [ Time Frame: 1, 2, 3, 4 years ] | ||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation. | ||||||||
| Official Title ICMJE | Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
1162 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 1, 2023 | ||||||||
| Estimated Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion criteria
Exclusion criteria
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 89 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04009434 | ||||||||
| Other Study ID Numbers ICMJE | MITAVI | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Technische Universität Dresden | ||||||||
| Study Sponsor ICMJE | Technische Universität Dresden | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Technische Universität Dresden | ||||||||
| Verification Date | February 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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