BridgeMD
New treatment option for Mitral Regurgitation
Official title HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
ClinicalTrials.gov ID: NCT04888247
What this study is testing
- What it's testing
- Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Moderate-severe or severe mitral regurgitation (≥ 3+)
- Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and...
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Moderate-severe or severe mitral regurgitation (≥ 3+)
- Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- 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
- Patient meets the anatomical criteria for HighLife valve
- Patient is willing to participate in the study and provides signed informed consent
- Patients with a high risk for LVOTO
- 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 \-
The study team makes the final eligibility decision.
Where it's taking place
- Auchenflower, Australia
- Perth, Australia
- Sydney, Australia
- Bruges, Belgium
- Leuven, Belgium
- Lille, France
- Nantes, France
- Rennes, France
- Toulouse, France
- Munich, Germany
- Ulm, Germany
- Katowice, Poland
- Warsaw, Poland
- Brighton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Auchenflower, Australia; Perth, Australia; Sydney, Australia; Bruges, Belgium; Leuven, Belgium; Lille, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.