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

Status: Recruiting
Location: See all (50) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
St. Andrew's Hospital
RECRUITING
Adelaide
The Wesley Hospital
RECRUITING
Auchenflower
Princess Alexandra Hospital
RECRUITING
Brisbane
St. Vincent's Hospital - Sydney
RECRUITING
Darlinghurst
Warringal Hospital
TERMINATED
Heidelberg
The Alfred Hospital
RECRUITING
Melbourne
John Hunter Hospital
RECRUITING
Newcastle
John Hunter Hospital
RECRUITING
Newcastle
Mount Hospital
RECRUITING
Perth
Macquarie University Hospital
WITHDRAWN
Sydney
North Shore Private Hospital
RECRUITING
Sydney
Belgium
ZNA Middelheim
RECRUITING
Antwerp
AZ Sint-Jan
RECRUITING
Bruges
UZ Leuven
RECRUITING
Leuven
France
CHU Lille
RECRUITING
Lille
Medipole Lyon-Villeurbanne
RECRUITING
Lyon
Hopital Prive - Jacques Cartier
RECRUITING
Massy
Centre Hospitalo-Universitaire de Nantes
RECRUITING
Nantes
European Hospital George Pompidou
TERMINATED
Paris
CHU Bordeaux
RECRUITING
Pessac
CHU de Rennes
RECRUITING
Rennes
Centr Cardiologiqque du Nord
RECRUITING
Saint-denis
CHRU Strasbourg
RECRUITING
Strasbourg
Clinque Pasteur
RECRUITING
Toulouse
Rangueil University Hospital
RECRUITING
Toulouse
Rangueil University Hospital
RECRUITING
Toulouse
Germany
University Heart Center Freiburg - Bad Krozingen
TERMINATED
Bad Krozingen
Universitaetsklinikum Bonn
RECRUITING
Bonn
Heart Center, University Hospital Dresden
RECRUITING
Dresden
Mediinisches Versorgungszentrum
RECRUITING
Hamburg
Universitatsklink Hamburg-Eppendorf
RECRUITING
Hamburg
University Hospital Heidelberg
TERMINATED
Heidelberg
Herzentrum Leipzig
RECRUITING
Leipzig
Deutsches Herzzentrum Munchen
RECRUITING
Munich
University Medicine Dept of Cardiology
TERMINATED
Rostock
University Hospital Ulm
RECRUITING
Ulm
Poland
Medical University of Gdansk
RECRUITING
Gdansk
Medical University of Silesia Hospital
RECRUITING
Katowice
University Hospital of Lord's Transfiguration
TERMINATED
Poznan
Institute of Cardiology
RECRUITING
Warsaw
Medical University of Warsaw
RECRUITING
Warsaw
Singapore
National Heart Center Singapore
RECRUITING
Singapore
United Kingdom
Royal Victoria Hospital
RECRUITING
Belfast
Brighton and Sussex University Hospital
RECRUITING
Brighton
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Leeds Teaching Hospitals NHS Trust
TERMINATED
Leeds
University Hospitals of Leicester NHS Trust
TERMINATED
Leicester
Barts Heart Center
TERMINATED
London
Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital
RECRUITING
London
John Radcliffe
TERMINATED
Oxford
Contact Information
Primary
Martin Rothman, MD
MRothman@highlifemed.com
+1 707 2177167
Time Frame
Start Date: 2019-05-28
Estimated Completion Date: 2031-12-15
Participants
Target number of participants: 120
Treatments
Other: Single arm
Single arm, non-randomized
Related Therapeutic Areas
Sponsors
Collaborators: ICON plc
Leads: HighLife SAS

This content was sourced from clinicaltrials.gov

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