Mitral RegurgitationNCT04029337
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
A study testing Transcatheter Mitral Valve Replacement in people with Mitral Regurgitation, run by HighLife SAS at 10 sites in United States.
Trial summary
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- 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
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Jul 2020to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
Piedmont Heart
Atlanta, Georgia, 30309
Pradeep Yadav, MD, (404) 605-5000, pradeep.yadav@piedmont.org
Pradeep Yadav, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pinank Shah, MD, +1 857-307-4000, pbshah@bwh.harvard.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Daniel Steinberg, MD, (843) 792-1414, steinbe@musc.edu
Daniel Steinberg, MD
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Sachin Goel, MD, (713) 790-3311, ssgoel@houstonmethodist.org
Sachin Goel, MD
- Recruiting
Los Robles Regional Medical Center
Los Angeles, California, 91360
Saibal Kar, MD, (805) 497-2727, saibalkar60@gmail.com
Saibal Kar, MD
- Recruiting
Minneapolis Heart
Minneapolis, Minnesota, 55407
Paul Sorajja, MD, (612) 863-3900, paul.sorajja@allina.com
Paul Sorajja, MD
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Azeem Latib, MD, (718) 920-4321, mlatib@montefiore.org
Azim Latib, MD
- Terminated
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Terminated
Chippenham Hospital Richmond
Richmond, Virginia, 23225
- Recruiting
Tucson Medical Center
Tucson, Arizona, 85712
Thomas Waggoner, MD, +1 520-838-3540, Thomas Waggoner <twaggoner.med@gmail.com>
About this study
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Read the detailed description
Protocol Title:
An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System
Protocol # HL-2019-01, ver. 5.0
Phase: United States Early Feasibility Study
Investigational Devices:
The HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System.
- Size 28 mm TMV (CLARITY valve)
- Size 28 mm TMV-L (CLARITY large annulus valve/ LAV)
Intended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR) due to primary (degenerative) or secondary (functional) abnormality of the mitral valve.
Device Description:
The HighLife TSMVR system is composed of a Trans-Septal (Mitral Valve (TSMV), a sub-annular implant (SAI), and their delivery systems and accessories. The TMV is a 28 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), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.
Design: A single arm, prospective, multicenter, non-randomized and open-labelled study.
Purpose: The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife 28mm Trans-septal Mitral Valve Replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment or deemed more appropriate to receive transcatheter mitral valve replacement than to receive conventional mitral valve surgery according to the local multidisciplinary Heart Team.
Objectives: Primary objectives are to evaluate the feasibility, safety and performance of the HighLife 28mm TSMVR system at 30 days. Secondary objectives are to evaluate long term safety and performance of the HighLife TSMVR system.
- Conditions
- Mitral Regurgitation
- 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. 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
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start14 Jul 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighLife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029337
- Sponsor's protocol ID
- HL-2019-01
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
- ClinicalTrials.gov ID
- NCT04029337
- Acronym / sponsor ID
- HL-2019-01
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Jul 2019 (actual)
- 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.
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Detailed description
Protocol Title:
An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System
Protocol # HL-2019-01, ver. 5.0
Phase: United States Early Feasibility Study
Investigational Devices:
The HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System.
- Size 28 mm TMV (CLARITY valve)
- Size 28 mm TMV-L (CLARITY large annulus valve/ LAV)
Intended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR) due to primary (degenerative) or secondary (functional) abnormality of the mitral valve.
Device Description:
The HighLife TSMVR system is composed of a Trans-Septal (Mitral Valve (TSMV), a sub-annular implant (SAI), and their delivery systems and accessories. The TMV is a 28 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), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.
Design: A single arm, prospective, multicenter, non-randomized and open-labelled study.
Purpose: The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife 28mm Trans-septal Mitral Valve Replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment or deemed more appropriate to receive transcatheter mitral valve replacement than to receive conventional mitral valve surgery according to the local multidisciplinary Heart Team.
Objectives: Primary objectives are to evaluate the feasibility, safety and performance of the HighLife 28mm TSMVR system at 30 days. Secondary objectives are to evaluate long term safety and performance of the HighLife TSMVR system.
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. |
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)
1 secondary outcome
Technical success
Time frame: immediately after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: 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 Regurgitation, run by HighLife SAS at 10 sites in United States.
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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.