MedDataX Logo

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

NCT ID: NCT04029363

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2031-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

NCT04888247

Mitral Regurgitation
RECRUITING NA

Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

NCT01531374

Severe Aortic Stenosis
COMPLETED NA

HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

NCT02157142

Severe Aortic Stenosis Aortic Valve Stenosis
COMPLETED NA

Valveclip® Transcatheter Mitral Valve Repair Study

NCT05021614

Mitral Regurgitation
RECRUITING NA

Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

NCT01675440

Severe Aortic Stenosis
ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm

Single arm, non-randomized

Group Type OTHER

HighLife Transcatheter Mitral Valve Replacement

Intervention Type DEVICE

Transcatheter Mitral Valve Replacement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HighLife Transcatheter Mitral Valve Replacement

Transcatheter Mitral Valve Replacement

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ICON plc

INDUSTRY

Sponsor Role collaborator

HighLife SAS

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Vincent's Hospital - Sydney

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

John Hunter Hospital

Newcastle, New South Wales, Australia

Site Status RECRUITING

Macquarie University Hospital

Sydney, New South Wales, Australia

Site Status WITHDRAWN

The Wesley Hospital

Auchenflower, Queensland, Australia

Site Status RECRUITING

St. Andrew's Hospital

Adelaide, , Australia

Site Status RECRUITING

Princess Alexandra Hospital

Brisbane, , Australia

Site Status RECRUITING

Warringal Hospital

Heidelberg, , Australia

Site Status TERMINATED

The Alfred Hospital

Melbourne, , Australia

Site Status RECRUITING

John Hunter Hospital

Newcastle, , Australia

Site Status RECRUITING

Mount Hospital

Perth, , Australia

Site Status RECRUITING

North Shore Private Hospital

Sydney, , Australia

Site Status RECRUITING

ZNA Middelheim

Antwerp, , Belgium

Site Status RECRUITING

AZ Sint-Jan

Bruges, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Rangueil University Hospital

Toulouse, Toulouse, France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

Medipole Lyon-Villeurbanne

Lyon, , France

Site Status RECRUITING

Hopital Prive - Jacques Cartier

Massy, , France

Site Status RECRUITING

Centre Hospitalo-Universitaire de Nantes

Nantes, , France

Site Status RECRUITING

European Hospital George Pompidou

Paris, , France

Site Status TERMINATED

CHU Bordeaux

Pessac, , France

Site Status RECRUITING

CHU de Rennes

Rennes, , France

Site Status RECRUITING

Centr Cardiologiqque du Nord

Saint-Denis, , France

Site Status RECRUITING

CHRU Strasbourg

Strasbourg, , France

Site Status RECRUITING

Clinque Pasteur

Toulouse, , France

Site Status RECRUITING

Rangueil University Hospital

Toulouse, , France

Site Status RECRUITING

University Heart Center Freiburg - Bad Krozingen

Bad Krozingen, , Germany

Site Status TERMINATED

Universitaetsklinikum Bonn

Bonn, , Germany

Site Status RECRUITING

Heart Center, University Hospital Dresden

Dresden, , Germany

Site Status RECRUITING

Universitatsklink Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Mediinisches Versorgungszentrum

Hamburg, , Germany

Site Status RECRUITING

University Hospital Heidelberg

Heidelberg, , Germany

Site Status TERMINATED

Herzentrum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Deutsches Herzzentrum Munchen

Munich, , Germany

Site Status RECRUITING

University Medicine Dept of Cardiology

Rostock, , Germany

Site Status TERMINATED

University Hospital Ulm

Ulm, , Germany

Site Status RECRUITING

Medical University of Gdansk

Gdansk, , Poland

Site Status RECRUITING

Medical University of Silesia Hospital

Katowice, , Poland

Site Status RECRUITING

University Hospital of Lord's Transfiguration

Poznan, , Poland

Site Status TERMINATED

Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Institute of Cardiology

Warsaw, , Poland

Site Status RECRUITING

National Heart Center Singapore

Singapore, , Singapore

Site Status RECRUITING

Royal Victoria Hospital

Belfast, , United Kingdom

Site Status RECRUITING

Brighton and Sussex University Hospital

Brighton, , United Kingdom

Site Status RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status TERMINATED

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status TERMINATED

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

London, , United Kingdom

Site Status RECRUITING

Barts Heart Center

London, , United Kingdom

Site Status TERMINATED

John Radcliffe

Oxford, , United Kingdom

Site Status TERMINATED

Countries

Review the countries where the study has at least one active or historical site.

Australia Belgium France Germany Poland Singapore United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martin Rothman, MD

Role: CONTACT

[email protected]
+1 707 2177167

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

David Muller, MD

Role: primary

[email protected]
+61 2 8382 2775

Allen Davies, MD

Role: primary

[email protected]
+61 (0) 24985 5433

Sam Haymen, MD

Role: primary

Joseph Montarello, MD

Role: primary

[email protected]
+61 412 764 909

Anthony Camuglia, MD

Role: primary

Antony Walton, MD

Role: primary

[email protected]
+61 414 332 444

Allan Davies, MD

Role: primary

Wen Yeow, MD

Role: primary

[email protected]
+61 412 764 909

Ravinay Bhindi

Role: primary

Pierfranceso Agostoni, MD

Role: primary

Jan van der Heyden, MD

Role: primary

[email protected]
+32 5045 2640

Christophe Dubois, MD

Role: primary

[email protected]
+3216344235

Eric van Belle

Role: primary

Pierre-Yves Leroux, MD

Role: primary

Thierry Lefevre

Role: primary

Vincent Letocart, MD

Role: primary

Lionel Leroux, MD

Role: primary

[email protected]
+33 557 656 518

Guillaume Leurent, MD

Role: primary

[email protected]
+33 299 28 2505

Mohammed Nejjari

Role: primary

Patrick Ohlmann, MD

Role: primary

Didier Tchetche, MD

Role: primary

[email protected]
+33 562 211 699

Lavie Badie, MD

Role: primary

Georg Nickenig, MD

Role: primary

[email protected]
+4922828715217

Jennifer Richter

Role: backup

[email protected]
+4922828714305

Axel Linke

Role: primary

Niklas Schofer, MD

Role: primary

Joachim Schofer, MD

Role: primary

Tobias Kister, MD

Role: primary

Michael Joner, MD

Role: primary

Wolfgang Rottbauer, MD

Role: primary

[email protected]
+49 731 500 45000

Radoslaw Targonski, MD

Role: primary

Wojciech Wojakowski, MD

Role: primary

[email protected]
+48 604 188 669

Zenon Huczek, MD

Role: primary

[email protected]
+48 692 433 568

Adam Witkowski, MD

Role: primary

[email protected]
+48 223 43 4127

Yeo Khung Keong, MD

Role: primary

Colum Owens

Role: primary

David Hildick-Smith, MD

Role: primary

[email protected]
+44 1273 696955 ext. 7687

Miles Behan, MD

Role: primary

Simon Redwood, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37999708 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HL-2018-01-TS Expanded EU/AU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation
NCT05770648 UNKNOWN NA
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
NCT02434263 UNKNOWN NA
Resynchronization Surgery Combined Unified Efficacy
NCT00846001 COMPLETED PHASE3
Mi-thos® Transcatheter Mitral Valve Replacement Study
NCT04195984 RECRUITING NA
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
NCT05064514 ACTIVE_NOT_RECRUITING NA
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
NCT07097740 RECRUITING NA
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
NCT04009434 UNKNOWN NA
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
NCT02701283 ACTIVE_NOT_RECRUITING NA
Degenerative Mitral Regurgitation in Intermediate Risk Patients
NCT02604745 COMPLETED
Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction
NCT04402931 COMPLETED NA
Cardiovalve Transfemoral System - FIM Study
NCT03958773 ENROLLING_BY_INVITATION NA
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
NCT05784337 COMPLETED NA
"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System
NCT07334691 RECRUITING NA
A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
NCT07045233 ENROLLING_BY_INVITATION
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
NCT00636987 COMPLETED NA
CoreValve® System Australia/New Zealand Clinical Study
NCT01015612 COMPLETED NA
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
NCT05864456 RECRUITING NA
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
NCT04936802 UNKNOWN NA
"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System
NCT05486832 RECRUITING NA
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
NCT05436028 COMPLETED NA
EDWARDS INTUITY Elite Valve System
NCT02907463 COMPLETED
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT02628899 COMPLETED NA
MRI in Transcatheter Aortic Valve Replacement Patients
NCT05603026 RECRUITING NA
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
NCT06196684 ACTIVE_NOT_RECRUITING
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
NCT06568003 ACTIVE_NOT_RECRUITING NA