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

September 9, 2025 updated by: HighLife SAS
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • St. Andrew's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Montarello, MD
      • Brisbane, Australia
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Anthony Camuglia, MD
        • Sub-Investigator:
          • Anthony Camuglia, MD
      • Heidelberg, Australia, 3084
        • Terminated
        • Warringal Hospital
      • Melbourne, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
      • Newcastle, Australia
        • Recruiting
        • John Hunter Hospital
        • Contact:
          • Allan Davies, MD
        • Principal Investigator:
          • Allan Davies
      • Perth, Australia, 6150
        • Recruiting
        • Mount Hospital
        • Contact:
        • Principal Investigator:
          • Wen Yeow, MD
      • Sydney, Australia
        • Recruiting
        • North Shore Private Hospital
        • Contact:
          • Ravinay Bhindi
        • Principal Investigator:
          • Ravinay Bhinddi
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent's Hospital - Sydney
        • Contact:
        • Principal Investigator:
          • David Muller, MD
      • Newcastle, New South Wales, Australia, 2305
      • Sydney, New South Wales, Australia, 2109
        • Withdrawn
        • Macquarie University Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • The Wesley Hospital
        • Contact:
          • Sam Haymen, MD
        • Principal Investigator:
          • Sam Haymen, MD
  • Belgium
      • Antwerp, Belgium, 2020
        • Recruiting
        • Zna Middelheim
        • Contact:
          • Pierfranceso Agostoni, MD
        • Principal Investigator:
          • Pierfrancesco Agostoni, MD
      • Bruges, Belgium, 8000
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Christophe Dubois, MD
  • France
      • Lille, France
        • Recruiting
        • CHU Lille
        • Contact:
          • Eric van Belle
        • Principal Investigator:
          • Eric van Belle
      • Lyon, France
        • Recruiting
        • Medipole Lyon-Villeurbanne
        • Contact:
          • Pierre-Yves Leroux, MD
        • Principal Investigator:
          • Pierre-Yves Leroux, MD
      • Massy, France
        • Recruiting
        • Hopital Prive - Jacques Cartier
        • Contact:
          • Thierry Lefevre
        • Principal Investigator:
          • Thierry Lefevre
      • Nantes, France
        • Recruiting
        • Centre Hospitalo-Universitaire de Nantes
        • Contact:
          • Vincent Letocart, MD
        • Principal Investigator:
          • Vincent Letocart, MD
      • Paris, France, 5015
        • Terminated
        • European Hospital George Pompidou
      • Pessac, France, 33600
      • Rennes, France, 35000
      • Saint-Denis, France
        • Recruiting
        • Centr Cardiologiqque du Nord
        • Contact:
          • Mohammed Nejjari
        • Principal Investigator:
          • Mohammed Nejjari
      • Strasbourg, France
        • Recruiting
        • CHRU Strasbourg
        • Contact:
          • Patrick Ohlmann, MD
        • Principal Investigator:
          • Patrick Ohlmann, MD
      • Toulouse, France, 31076
      • Toulouse, France
        • Recruiting
        • Rangueil University Hospital
        • Contact:
          • Lavie Badie, MD
        • Principal Investigator:
          • Lavie Badie, MD
    • Toulouse
      • Toulouse, Toulouse, France, 31400
        • Recruiting
        • Rangueil University Hospital
  • Germany
      • Bad Krozingen, Germany, 79189
        • Terminated
        • University Heart Center Freiburg - Bad Krozingen
      • Bonn, Germany, 53127
        • Recruiting
        • Universitaetsklinikum Bonn
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georg Nickenig, MD
      • Dresden, Germany
        • Recruiting
        • Heart Center, University Hospital Dresden
        • Contact:
          • Axel Linke
        • Principal Investigator:
          • Axel Linke
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitatsklink Hamburg-Eppendorf
        • Principal Investigator:
          • Niklas Schofer, MD
        • Contact:
          • Niklas Schofer, MD
      • Hamburg, Germany
        • Recruiting
        • Mediinisches Versorgungszentrum
        • Principal Investigator:
          • Joachim Schofer, MD
        • Contact:
          • Joachim Schofer, MD
      • Heidelberg, Germany
        • Terminated
        • University Hospital Heidelberg
      • Leipzig, Germany, 04289
        • Recruiting
        • Herzentrum Leipzig
        • Principal Investigator:
          • Tobias Kister, MD
        • Contact:
          • Tobias Kister, MD
      • Munich, Germany
        • Recruiting
        • Deutsches Herzzentrum München
        • Contact:
          • Michael Joner, MD
        • Principal Investigator:
          • Michael Joner, MD
      • Rostock, Germany
        • Terminated
        • University Medicine Dept of Cardiology
      • Ulm, Germany, 89081
        • Recruiting
        • University Hospital Ulm
        • Contact:
        • Principal Investigator:
          • Wolfgang Rottbauer, MD
  • Poland
      • Gdansk, Poland
        • Recruiting
        • Medical University of Gdańsk
        • Contact:
          • Radoslaw Targonski, MD
        • Principal Investigator:
          • Radoslaw Targonski, MD
      • Katowice, Poland, 40-635
        • Recruiting
        • Medical University of Silesia Hospital
        • Contact:
        • Principal Investigator:
          • Wojciech Wojakowski, MD
      • Poznan, Poland, 61-848
        • Terminated
        • University Hospital of Lord's Transfiguration
      • Warsaw, Poland, 02-097
        • Recruiting
        • Medical University of Warsaw
        • Contact:
          • Zenon Huczek, MD
          • Phone Number: +48 692 433 568
          • Email: zhuczek@wp.pl
      • Warsaw, Poland, 04-628
        • Recruiting
        • Institute of Cardiology
        • Contact:
        • Principal Investigator:
          • Adam Witkowski, MD
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Heart Center Singapore
        • Contact:
          • Yeo Khung Keong, MD
        • Principal Investigator:
          • Yeo Khung Keong, MD
  • United Kingdom
      • Belfast, United Kingdom
        • Recruiting
        • Royal Victoria Hospital
        • Contact:
          • Colum Owens
        • Principal Investigator:
          • Colum Owens
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • Brighton and Sussex University Hospital
        • Contact:
      • Edinburgh, United Kingdom
        • Recruiting
        • Royal Infirmary of Edinburgh
        • Contact:
          • Miles Behan, MD
        • Principal Investigator:
          • Miles Behan, MD
      • Leeds, United Kingdom
        • Terminated
        • Leeds Teaching Hospitals NHS Trust
      • Leicester, United Kingdom
        • Terminated
        • University Hospitals of Leicester NHS Trust
      • London, United Kingdom, SE1 9RS
        • Recruiting
        • Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital
        • Contact:
          • Simon Redwood, MD
      • London, United Kingdom
        • Terminated
        • Barts Heart Center
      • Oxford, United Kingdom
        • Terminated
        • John Radcliffe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Any stroke/TIA within 30 days
  2. Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
  3. Active infections requiring antibiotic therapy
  4. Active ulcer or gastro-intestinal bleeding in the past 3 months
  5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
  6. Patients in whom TEE is not feasible
  7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
  8. Patient is unable to comply with the follow-up schedule and assessments
  9. Participation in another clinical investigation at the time of inclusion
  10. Patient has known allergies to the device components or contrast medium
  11. Patient cannot tolerate anticoagulation or antiplatelet therapy
  12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions

  13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
Single arm, non-randomized
Device: HighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Safety
Time Frame: 30 days
Freedom from major adverse events
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HighLife SAS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ICON plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HL-2018-01-TS Expanded EU/AU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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