Actively Recruiting
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
Led by HighLife SAS · Updated on 2025-09-15
120
Participants Needed
50
Research Sites
654 weeks
Total Duration
On this page
Sponsors
H
HighLife SAS
Lead Sponsor
I
ICON plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Moderate-severe or severe mitral regurgitation (3+ or greater)
- New York Heart Association Functional Class II, III, or ambulatory IV
- Under guideline-directed medical therapy for at least one month, confirmed by Heart Team
- High risk for open-heart surgery based on Heart Team assessment including scoring systems, co-morbidities, frailty, and disability
- Meets anatomical criteria for HighLife valve
- Willing to participate and provides signed informed consent
You will not qualify if you...
- Stroke or transient ischemic attack within 30 days
- Severe symptomatic carotid stenosis greater than 70% by non-invasive imaging
- Active infections that require antibiotic treatment
- Active ulcer or gastrointestinal bleeding within past 3 months
- History of bleeding disorders, coagulopathy, or refusal of future blood transfusion
- Transesophageal echocardiography not feasible
- Pregnant, lactating, or planning pregnancy within next 12 months
- Unable to comply with follow-up schedule and assessments
- Participation in another clinical trial at enrollment
- Known allergies to device components or contrast medium
- Cannot tolerate anticoagulation or antiplatelet therapy
- Life expectancy less than 12 months due to non-cardiac conditions
- Permanent pacemaker or similar device with cardiac leads implanted within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
St. Vincent's Hospital - Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
3
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Withdrawn
4
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
5
St. Andrew's Hospital
Adelaide, Australia, 5000
Actively Recruiting
6
Princess Alexandra Hospital
Brisbane, Australia
Actively Recruiting
7
Warringal Hospital
Heidelberg, Australia, 3084
Terminated
8
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
9
John Hunter Hospital
Newcastle, Australia
Actively Recruiting
10
Mount Hospital
Perth, Australia, 6150
Actively Recruiting
11
North Shore Private Hospital
Sydney, Australia
Actively Recruiting
12
ZNA Middelheim
Antwerp, Belgium, 2020
Actively Recruiting
13
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
14
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
15
Rangueil University Hospital
Toulouse, Toulouse, France, 31400
Actively Recruiting
16
CHU Lille
Lille, France
Actively Recruiting
17
Medipole Lyon-Villeurbanne
Lyon, France
Actively Recruiting
18
Hopital Prive - Jacques Cartier
Massy, France
Actively Recruiting
19
Centre Hospitalo-Universitaire de Nantes
Nantes, France
Actively Recruiting
20
European Hospital George Pompidou
Paris, France, 5015
Terminated
21
CHU Bordeaux
Pessac, France, 33600
Actively Recruiting
22
CHU de Rennes
Rennes, France, 35000
Actively Recruiting
23
Centr Cardiologiqque du Nord
Saint-Denis, France
Actively Recruiting
24
CHRU Strasbourg
Strasbourg, France
Actively Recruiting
25
Clinque Pasteur
Toulouse, France, 31076
Actively Recruiting
26
Rangueil University Hospital
Toulouse, France
Actively Recruiting
27
University Heart Center Freiburg - Bad Krozingen
Bad Krozingen, Germany, 79189
Terminated
28
Universitaetsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
29
Heart Center, University Hospital Dresden
Dresden, Germany
Actively Recruiting
30
Universitatsklink Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
31
Mediinisches Versorgungszentrum
Hamburg, Germany
Actively Recruiting
32
University Hospital Heidelberg
Heidelberg, Germany
Terminated
33
Herzentrum Leipzig
Leipzig, Germany, 04289
Actively Recruiting
34
Deutsches Herzzentrum Munchen
Munich, Germany
Actively Recruiting
35
University Medicine Dept of Cardiology
Rostock, Germany
Terminated
36
University Hospital Ulm
Ulm, Germany, 89081
Actively Recruiting
37
Medical University of Gdansk
Gdansk, Poland
Actively Recruiting
38
Medical University of Silesia Hospital
Katowice, Poland, 40-635
Actively Recruiting
39
University Hospital of Lord's Transfiguration
Poznan, Poland, 61-848
Terminated
40
Medical University of Warsaw
Warsaw, Poland, 02-097
Actively Recruiting
41
Institute of Cardiology
Warsaw, Poland, 04-628
Actively Recruiting
42
National Heart Center Singapore
Singapore, Singapore
Actively Recruiting
43
Royal Victoria Hospital
Belfast, United Kingdom
Actively Recruiting
44
Brighton and Sussex University Hospital
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
45
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Actively Recruiting
46
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Terminated
47
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Terminated
48
Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital
London, United Kingdom, SE1 9RS
Actively Recruiting
49
Barts Heart Center
London, United Kingdom
Terminated
50
John Radcliffe
Oxford, United Kingdom
Terminated
Research Team
M
Martin Rothman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here