Mitral RegurgitationNCT04029363
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
A study testing HighLife Transcatheter Mitral Valve Replacement in people with Mitral Regurgitation, run by HighLife SAS at 50 sites in 7 countries.
Trial summary
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or 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?
- HighLife Transcatheter Mitral Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 50 sitesin 7 countries
- Study dates
- 28 May 2019to 15 Dec 2031
- 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
- 1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent
Who cannot join
- Any stroke/TIA within 30 days
- Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- Active infections requiring antibiotic therapy
- Active ulcer or gastro-intestinal bleeding in the past 3 months
- History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
- Patients in whom TEE is not feasible
Show all 14Show fewer
- Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
- Patient is unable to comply with the follow-up schedule and assessments
- Participation in another clinical investigation at the time of inclusion
- Patient has known allergies to the device components or contrast medium
- Patient cannot tolerate anticoagulation or antiplatelet therapy
- Patients with a life expectancy of less than 12 months due to non-cardiac conditions
- Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
- -
Trial locations and contacts
50 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 7 countries
France12 sites, 11 recruiting
- Recruiting
CHU Lille
Lille
Eric van Belle
Eric van Belle
- Recruiting
Medipole Lyon-Villeurbanne
Lyon
Pierre-Yves Leroux, MD
Pierre-Yves Leroux, MD
- Recruiting
Hopital Prive - Jacques Cartier
Massy
Thierry Lefevre
Thierry Lefevre
- Recruiting
Centre Hospitalo-Universitaire de Nantes
Nantes
Vincent Letocart, MD
Vincent Letocart, MD
- Terminated
European Hospital George Pompidou
Paris, 5015
- Recruiting
CHU Bordeaux
Pessac, 33600
Lionel Leroux, MD, +33 557 656 518, lionel.leroux@chu-bordeaux.fr
- Recruiting
CHU de Rennes
Rennes, 35000
Guillaume Leurent, MD, +33 299 28 2505, guillaume.leurent@chu-rennes.fr
- Recruiting
Centr Cardiologiqque du Nord
Saint-Denis
Mohammed Nejjari
Mohammed Nejjari
- Recruiting
CHRU Strasbourg
Strasbourg
Patrick Ohlmann, MD
Patrick Ohlmann, MD
- Recruiting
Rangueil University Hospital
Toulouse, Toulouse, 31400
- Recruiting
Clinque Pasteur
Toulouse, 31076
Didier Tchetche, MD, +33 562 211 699, dtchetche@clinique-pasteur.com
- Recruiting
Rangueil University Hospital
Toulouse
Lavie Badie, MD
Lavie Badie, MD
Australia11 sites, 9 recruiting
- Recruiting
St. Andrew's Hospital
Adelaide, 5000
Joseph Montarello, MD, +61 412 764 909, Sonya.McColl@genesiscare.com
Joseph Montarello, MD
- Recruiting
The Wesley Hospital
Auchenflower, Queensland, 4066
Sam Haymen, MD
Sam Haymen, MD
- Recruiting
Princess Alexandra Hospital
Brisbane
Anthony Camuglia, MD
Anthony Camuglia, MD
- Recruiting
St. Vincent's Hospital - Sydney
Darlinghurst, New South Wales, 2010
David Muller, MD, +61 2 8382 2775, dmuller@stvincents.com.au
David Muller, MD
- Terminated
Warringal Hospital
Heidelberg, 3084
- Recruiting
The Alfred Hospital
Melbourne, 3004
Antony Walton, MD, +61 414 332 444, twalton93@me.com
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Allen Davies, MD, +61 (0) 24985 5433, allan.davies@health.nsw.gov.au
- Recruiting
John Hunter Hospital
Newcastle
Allan Davies, MD
Allan Davies
- Recruiting
Mount Hospital
Perth, 6150
Wen Yeow, MD, +61 412 764 909, Sonya.McColl@genesiscare.com
Wen Yeow, MD
- Withdrawn
Macquarie University Hospital
Sydney, New South Wales, 2109
- Recruiting
North Shore Private Hospital
Sydney
Ravinay Bhindi
Ravinay Bhinddi
Germany10 sites, 7 recruiting
- Terminated
University Heart Center Freiburg - Bad Krozingen
Bad Krozingen, 79189
- Recruiting
Universitaetsklinikum Bonn
Bonn, 53127
Georg Nickenig, MD, +4922828715217, georg.nickenig@ukbonn.de
Jennifer Richter, +4922828714305, jennifer.richter@ukbonn.de
- Recruiting
Heart Center, University Hospital Dresden
Dresden
Axel Linke
Axel Linke
- Recruiting
Universitatsklink Hamburg-Eppendorf
Hamburg, 20246
Niklas Schofer, MD
Niklas Schofer, MD
- Recruiting
Mediinisches Versorgungszentrum
Hamburg
Joachim Schofer, MD
Joachim Schofer, MD
- Terminated
University Hospital Heidelberg
Heidelberg
- Recruiting
Herzentrum Leipzig
Leipzig, 04289
Tobias Kister, MD
Tobias Kister, MD
- Recruiting
Deutsches Herzzentrum Munchen
Munich
Michael Joner, MD
Michael Joner, MD
- Terminated
University Medicine Dept of Cardiology
Rostock
- Recruiting
University Hospital Ulm
Ulm, 89081
Wolfgang Rottbauer, MD, +49 731 500 45000, wolfgang.rottbauer@uniklinik-ulm.de
Wolfgang Rottbauer, MD
United Kingdom8 sites, 4 recruiting
- Recruiting
Royal Victoria Hospital
Belfast
Colum Owens
Colum Owens
- Recruiting
Brighton and Sussex University Hospital
Brighton, BN2 5BE
David Hildick-Smith, MD, +44 1273 696955 ext. 7687, david.hildick-smith@bsuh.nhs.uk
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh
Miles Behan, MD
Miles Behan, MD
- Terminated
Leeds Teaching Hospitals NHS Trust
Leeds
- Terminated
University Hospitals of Leicester NHS Trust
Leicester
- Recruiting
Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital
London, SE1 9RS
Simon Redwood, MD
- Terminated
Barts Heart Center
London
- Terminated
John Radcliffe
Oxford
Poland5 sites, 4 recruiting
- Recruiting
Medical University of Gdansk
Gdansk
Radoslaw Targonski, MD
Radoslaw Targonski, MD
- Recruiting
Medical University of Silesia Hospital
Katowice, 40-635
Wojciech Wojakowski, MD, +48 604 188 669, wwojakowski@sum.edu.pl
Wojciech Wojakowski, MD
- Terminated
University Hospital of Lord's Transfiguration
Poznan, 61-848
- Recruiting
Medical University of Warsaw
Warsaw, 02-097
Zenon Huczek, MD, +48 692 433 568, zhuczek@wp.pl
- Recruiting
Institute of Cardiology
Warsaw, 04-628
Adam Witkowski, MD, +48 223 43 4127, witkowski@hbz.pl
Adam Witkowski, MD
Belgium3 sites, 3 recruiting
- Recruiting
ZNA Middelheim
Antwerp, 2020
Pierfranceso Agostoni, MD
Pierfrancesco Agostoni, MD
- Recruiting
AZ Sint-Jan
Bruges, 8000
Jan van der Heyden, MD, +32 5045 2640, jan.vanderheyden@azsintjan.be
- Recruiting
UZ Leuven
Leuven, 3000
Christophe Dubois, MD, +3216344235, christophe.dubois@uzleuven.be
Christophe Dubois, MD
Singapore1 site, 1 recruiting
- Recruiting
National Heart Center Singapore
Singapore
Yeo Khung Keong, MD
Yeo Khung Keong, MD
About this study
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Conditions
- Mitral Regurgitation
- Being tested
- HighLife 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.
HighLife Transcatheter Mitral Valve ReplacementDevice
Transcatheter Mitral Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm, non-randomized Receives: Device: HighLife Transcatheter Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Freedom from major adverse events
Measured: 30 days
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 start28 May 2019
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighLife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029363
- Sponsor's protocol ID
- HL-2018-01-TS Expanded EU/AU
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider LM, Worthley S, Nickenig G, Huczek Z, Wojakowski W, Tchetche D, Dubois C, Nasr M, Verhees L, Rothman M, Piazza N, Buithieu J, Yeow WL, Kessler M, Rottbauer W. 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. JACC Cardiovasc Interv. 2023 Dec 11;16(23):2854-2865. doi: 10.1016/j.jcin.2023.09.003. Epub 2023 Nov 22.
PubMed 37999708
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
- ClinicalTrials.gov ID
- NCT04029363
- Acronym / sponsor ID
- HL-2018-01-TS Expanded EU/AU
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 28 May 2019 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2031 (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.
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: HighLife Transcatheter Mitral Valve ReplacementSingle arm, non-randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent
Key exclusion criteria (14 listed)
- Any stroke/TIA within 30 days
- Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- Active infections requiring antibiotic therapy
- Active ulcer or gastro-intestinal bleeding in the past 3 months
- History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
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 |
|---|---|---|
| HighLife Transcatheter Mitral Valve ReplacementTranscatheter Mitral Valve Replacement | Device | Single arm |
Primary outcome
Device Safety
Time frame: 30 days
Freedom from major adverse events
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 15 Sep 2025.
- Derived from this study: PubMed 37999708Schneider LM, Worthley S, Nickenig G, Huczek Z, Wojakowski W, Tchetche D, Dubois C, Nasr M, Verhees L, Rothman M, Piazza N, Buithieu J, Yeow WL, Kessler M, Rottbauer W. 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. JACC Cardiovasc Interv. 2023 Dec 11;16(23):2854-2865. doi: 10.1016/j.jcin.2023.09.003. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HighLife Transcatheter Mitral Valve Replacement in people with Mitral Regurgitation, run by HighLife SAS at 50 sites in 7 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 1 inclusion and 14 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France, Australia, Germany, United Kingdom, Poland and 2 more countries. 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?
Contact Martin Rothman, MD (+1 707 2177167, MRothman@highlifemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: 30 days). 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 NCT04029363, which also lists 1 linked publication.
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 15 Sep 2025.