Actively Recruiting
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Led by HighLife SAS · Updated on 2024-10-03
30
Participants Needed
14
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
CONDITIONS
Official Title
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
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 (NYHA) Functional Class II, III, or ambulatory IV
- Under guideline-directed medical therapy for at least one month as confirmed by the Heart Team
- Assessed as high risk for open-heart surgery by the multidisciplinary Heart Team
- Meets anatomical criteria for HighLife valve
- Willing to participate and provides signed informed consent
- High risk for left ventricular outflow tract obstruction (LVOTO)
You will not qualify if you...
- Stroke or transient ischemic attack (TIA) within 30 days
- Severe symptomatic carotid stenosis (greater than 70% by imaging)
- Active infections requiring antibiotics
- Active ulcer or gastrointestinal bleeding within the past 3 months
- History of bleeding disorders, coagulopathy, or refusal of blood transfusion
- Inability to undergo transesophageal echocardiography (TEE)
- Pregnant, lactating, or planning pregnancy within 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 implanted cardiac device within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Wesley Hospital
Auchenflower, Australia
Actively Recruiting
2
Mount Hospital
Perth, Australia
Actively Recruiting
3
Macquarie University Hospital
Sydney, Australia
Terminated
4
AZ St. Jan - Brugge
Bruges, Belgium
Actively Recruiting
5
UZ Leuven
Leuven, Belgium
Actively Recruiting
6
CHU Lille
Lille, France, 59000
Actively Recruiting
7
Centre Hospitalo - Univ de Nantes
Nantes, France, 44000
Actively Recruiting
8
CHU de Rennes
Rennes, France
Actively Recruiting
9
Cliniue Pasteur
Toulouse, France, 31076
Actively Recruiting
10
Deutsches Herzzentrum Munchen
Munich, Germany
Actively Recruiting
11
University Hospital Ulm
Ulm, Germany
Actively Recruiting
12
Medical University of Silesia
Katowice, Poland
Actively Recruiting
13
Medical University of Warsaw
Warsaw, Poland
Actively Recruiting
14
Brighton and Sussex University Hospital
Brighton, United Kingdom
Actively Recruiting
Research Team
L
Luc Verhees
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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