Mitral Valve RegurgitationNCT02974881
HighLife™ Transcatheter Mitral Valve Replacement System Study
A study testing Transcatheter Mitral Valve Replacement in people with Mitral Valve Regurgitation and Mitral Valve Insufficiency, run by HighLife SAS at 10 sites in 2 countries.
Trial summary
Multicenter feasibility study of the HighLife™ TMVR system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation, Mitral Valve Insufficiency
- What is being tested?
- Transcatheter Mitral Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 Jul 2017to 16 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Severe mitral regurgitation
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
- Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
- Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
- Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
Show all 20Show fewer
- Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE
- Main Exclusion Criteria:
- Mitral stenosis
- Rheumatic valve disease
- Severe calcifications of the mitral annulus and/or mitral leaflets
- Prior surgical or interventional treatment of the mitral valve
- Unsuitable anatomy for the transapical access
- Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
- Untreated clinically significant coronary artery disease requiring revascularization
- LVEF < 30%
- LVEDD > 70mm
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure
Who cannot join
None listed.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France6 sites
CHRU Lille
Lille, 59000
Hôpital Privé Jacques Cartier
Massy, 91300
CHU Nantes
Nantes, 44000
Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
Paris, 75013
CHU Rennes Pontchaillou
Rennes, 35000
CHU Toulouse Rangueil
Toulouse
Germany4 sites
Universitätsklinikum
Bonn
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, 04289
Deutsches Herzzentrum München des Freistaates Bayern
Munich, 80636
About this study
Official title: HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
Multicenter feasibility study of the HighLife™ TMVR system.
Read the detailed description
This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.
All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.
- Being tested
- Transcatheter Mitral Valve Replacement
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Mitral Valve ReplacementDevice
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
| Study group | Role | What they receive |
|---|---|---|
| transcatheter mitral valve replacement | Experimental | HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools. The HighLife Valve is a 31 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI). Receives: Device: Transcatheter Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of major adverse events
including:
- All-cause mortality
- Myocardial infarction or coronary ischemia requiring PCI or CABG
- Major stroke
- Life-threatening bleeding (MVARC scale)
- Major access and vascular complications
- Stage 2 or 3 acute kidney injury (includes dialysis)
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H
Measured: at 30 days post procedure
Continued intended performance of the HighLife™ bioprosthesis
defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient < 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)
Measured: at 30 days post procedure
Technical success
defined as alive patient at exit from procedure room, with all of the following:
- Successful access, delivery and retrieval of the HighLife delivery systems
- Deployment and correct positioning of the HighLife bioprosthesis
- Freedom of additional emergency surgery or re-intervention related to the device or access procedure
Measured: immediately after procedure
Secondary outcomes (6)
Device Success (per MVARC definitions)
per MVARC definition
Measured: At 30 days, 6 months and 12 months post procedure
Procedure Success
per MVARC definition
Measured: At 30 days, 6 months and 12 months post procedure
Patient Success
per MVARC definition
Measured: At 30 days, 6 months and 12 months post procedure
Hemodynamic Performance vs. Baseline
Echocardiographic evaluation
Measured: At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
Functional Improvement vs. Baseline
New York Heart Association Class 6-Minute Walk Test
Measured: At 30 days, 6 months and 12 months
Quality of Life Improvement vs. Baseline
Kansas City Cardiomyopathy Questionnaire
Measured: At 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start20 Jul 2017
- Primary completion18 Nov 2018
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- HighLife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International, ICON plc
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Collet, MD, Principal investigator, Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974881
- Sponsor's protocol ID
- HL-2016-01
- Status last verified
- Oct 2024
- First submitted
- 11 Nov 2016
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available.
PubMed 27640044Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.
PubMed 26184623Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.
PubMed 28838477
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
- ClinicalTrials.gov ID
- NCT02974881
- Acronym / sponsor ID
- HL-2016-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International, ICON plc
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter feasibility study of the HighLife™ TMVR system.
Detailed description
This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.
All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcatheter mitral valve replacement | Experimental | Device: Transcatheter Mitral Valve ReplacementHighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools. The HighLife Valve is a 31 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years
- Severe mitral regurgitation
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
- Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
- Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Mitral Valve ReplacementMinimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system | Device | transcatheter mitral valve replacement |
Primary outcome
Freedom of major adverse events
Time frame: at 30 days post procedure
including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H
Continued intended performance of the HighLife™ bioprosthesis
Time frame: at 30 days post procedure
defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient < 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)
Technical success
Time frame: immediately after procedure
defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife bioprosthesis * Freedom of additional emergency surgery or re-intervention related to the device or access procedure
6 secondary outcomes
Device Success (per MVARC definitions)
Time frame: At 30 days, 6 months and 12 months post procedure
Procedure Success
Time frame: At 30 days, 6 months and 12 months post procedure
Patient Success
Time frame: At 30 days, 6 months and 12 months post procedure
Hemodynamic Performance vs. Baseline
Time frame: At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
Functional Improvement vs. Baseline
Time frame: At 30 days, 6 months and 12 months
Quality of Life Improvement vs. Baseline
Time frame: At 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 27640044Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available.
- Background: PubMed 26184623Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.
- Background: PubMed 28838477Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Collet, MD principal investigator
Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Mitral Valve Replacement in people with Mitral Valve Regurgitation and Mitral Valve Insufficiency, run by HighLife SAS at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of major adverse events (time frame: at 30 days post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02974881, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.