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Recruiting NCT04029363

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

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HighLife Transcatheter Mitral Valve Replacement.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Belgium, France, Germany, Poland +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device HighLife Transcatheter Mitral Valve Replacement
    Transcatheter Mitral Valve Replacement

Primary outcome measures

  • Device Safety [Time frame: 30 days]

Eligibility criteria

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

  • 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
  • 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 12 centers
  • Rangueil University Hospital — Toulouse
  • CHU Lille — Lille
  • Medipole Lyon-Villeurbanne — Lyon
  • Hopital Prive - Jacques Cartier — Massy
  • Centre Hospitalo-Universitaire de Nantes — Nantes
  • European Hospital George Pompidou — Paris
  • CHU Bordeaux — Pessac
  • CHU de Rennes — Rennes
  • … and 4 more centers
Australia · 11 centers
  • St. Vincent's Hospital - Sydney — Darlinghurst
  • John Hunter Hospital — Newcastle
  • Macquarie University Hospital — Sydney
  • The Wesley Hospital — Auchenflower
  • St. Andrew's Hospital — Adelaide
  • Princess Alexandra Hospital — Brisbane
  • Warringal Hospital — Heidelberg
  • The Alfred Hospital — Melbourne
  • … and 3 more centers
Germany · 10 centers
  • University Heart Center Freiburg - Bad Krozingen — Bad Krozingen
  • Universitaetsklinikum Bonn — Bonn
  • Heart Center, University Hospital Dresden — Dresden
  • Universitatsklink Hamburg-Eppendorf — Hamburg
  • Mediinisches Versorgungszentrum — Hamburg
  • University Hospital Heidelberg — Heidelberg
  • Herzentrum Leipzig — Leipzig
  • Deutsches Herzzentrum Munchen — Munich
  • … and 2 more centers
United Kingdom · 8 centers
  • Royal Victoria Hospital — Belfast
  • Brighton and Sussex University Hospital — Brighton
  • Royal Infirmary of Edinburgh — Edinburgh
  • Leeds Teaching Hospitals NHS Trust — Leeds
  • University Hospitals of Leicester NHS Trust — Leicester
  • Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital — London
  • Barts Heart Center — London
  • John Radcliffe — Oxford
Poland · 5 centers
  • Medical University of Gdansk — Gdansk
  • Medical University of Silesia Hospital — Katowice
  • University Hospital of Lord's Transfiguration — Poznan
  • Medical University of Warsaw — Warsaw
  • Institute of Cardiology — Warsaw
Belgium · 3 centers
  • ZNA Middelheim — Antwerp
  • AZ Sint-Jan — Bruges
  • UZ Leuven — Leuven
Singapore · 1 center
  • National Heart Center Singapore — Singapore

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 2 PMID 37999708

Identifiers

NCT: NCT04029363 · HL-2018-01-TS Expanded EU/AU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗