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

NCT04029363 | Recruiting DMC

• 1 other identifier: HL-2018-01-TS Expanded EU/AU
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 50

Brief 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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Device Safety

  Freedom from major adverse events

  30 days

Study Arms (1)

Single arm

OTHER

Single arm, non-randomized

Device: HighLife Transcatheter Mitral Valve Replacement

Interventions

HighLife Transcatheter Mitral Valve Replacement DEVICE

Transcatheter Mitral Valve Replacement

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• HighLife SAS: lead
• ICON plc: collaborator

Study Sites (50)

St. Vincent's Hospital - Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

WITHDRAWN

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

RECRUITING

St. Andrew's Hospital

Adelaide, 5000, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Australia

RECRUITING

Warringal Hospital

Heidelberg, 3084, Australia

TERMINATED

The Alfred Hospital

Melbourne, 3004, Australia

RECRUITING

John Hunter Hospital

Newcastle, Australia

RECRUITING

Mount Hospital

Perth, 6150, Australia

RECRUITING

North Shore Private Hospital

Sydney, Australia

RECRUITING

ZNA Middelheim

Antwerp, 2020, Belgium

RECRUITING

AZ Sint-Jan

Bruges, 8000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Rangueil University Hospital

Toulouse, Toulouse, 31400, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Medipole Lyon-Villeurbanne

Lyon, France

RECRUITING

Hopital Prive - Jacques Cartier

Massy, France

RECRUITING

Centre Hospitalo-Universitaire de Nantes

Nantes, France

RECRUITING

European Hospital George Pompidou

Paris, 5015, France

TERMINATED

CHU Bordeaux

Pessac, 33600, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

RECRUITING

Centr Cardiologiqque du Nord

Saint-Denis, France

RECRUITING

CHRU Strasbourg

Strasbourg, France

RECRUITING

Clinque Pasteur

Toulouse, 31076, France

RECRUITING

Rangueil University Hospital

Toulouse, France

RECRUITING

University Heart Center Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

TERMINATED

Universitaetsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Heart Center, University Hospital Dresden

Dresden, Germany

RECRUITING

Universitatsklink Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Mediinisches Versorgungszentrum

Hamburg, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

TERMINATED

Herzentrum Leipzig

Leipzig, 04289, Germany

RECRUITING

Deutsches Herzzentrum Munchen

Munich, Germany

RECRUITING

University Medicine Dept of Cardiology

Rostock, Germany

TERMINATED

University Hospital Ulm

Ulm, 89081, Germany

RECRUITING

Medical University of Gdansk

Gdansk, Poland

RECRUITING

Medical University of Silesia Hospital

Katowice, 40-635, Poland

RECRUITING

University Hospital of Lord's Transfiguration

Poznan, 61-848, Poland

TERMINATED

Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

Institute of Cardiology

Warsaw, 04-628, Poland

RECRUITING

National Heart Center Singapore

Singapore, Singapore

RECRUITING

Royal Victoria Hospital

Belfast, United Kingdom

RECRUITING

Brighton and Sussex University Hospital

Brighton, BN2 5BE, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

TERMINATED

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

TERMINATED

Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

London, SE1 9RS, United Kingdom

RECRUITING

Barts Heart Center

London, United Kingdom

TERMINATED

John Radcliffe

Oxford, United Kingdom

TERMINATED

Related Publications (1)

• 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.

  PMID: 37999708 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Martin Rothman, MD

CONTACT

+1 707 2177167; MRothman@highlifemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 23, 2019
• Study Start: May 28, 2019
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2031
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); GB (8); BE (3); FR (12); AU (11); DE (10); PL (5)