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Recruiting NCT04888247

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

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: CLARITY.
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 +1
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 →

Official title

HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

Overview

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Detailed description

Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).

Interventions

  • Device CLARITY
    Trans-septal mitral valve replacement

Primary outcome measures

  • Rate of subjects meeting Technical Success [Time frame: 24 hours]

Eligibility criteria

Inclusion 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

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

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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 · 4 centers
  • CHU Lille — Lille
  • Centre Hospitalo - Univ de Nantes — Nantes
  • CHU de Rennes — Rennes
  • Cliniue Pasteur — Toulouse
Australia · 3 centers
  • Wesley Hospital — Auchenflower
  • Mount Hospital — Perth
  • Macquarie University Hospital — Sydney
Belgium · 2 centers
  • AZ St. Jan - Brugge — Bruges
  • UZ Leuven — Leuven
Germany · 2 centers
  • Deutsches Herzzentrum Munchen — Munich
  • University Hospital Ulm — Ulm
Poland · 2 centers
  • Medical University of Silesia — Katowice
  • Medical University of Warsaw — Warsaw
United Kingdom · 1 center
  • Brighton and Sussex University Hospital — Brighton

Identifiers

NCT: NCT04888247 · HL-2021-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗