NCT04888247

Brief Summary

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
58mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
6 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2021Feb 2031

First Submitted

Initial submission to the registry

May 4, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Expected
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

4.4 years

First QC Date

May 4, 2021

Last Update Submit

October 1, 2024

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Rate of subjects meeting Technical Success

    * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE

    24 hours

Study Arms (1)

Treatment

EXPERIMENTAL

Trans-septal mitral valve replacement

Device: CLARITY

Interventions

CLARITYDEVICE

Trans-septal mitral valve replacement

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Wesley Hospital

Auchenflower, Australia

RECRUITING

Mount Hospital

Perth, Australia

RECRUITING

Macquarie University Hospital

Sydney, Australia

TERMINATED

AZ St. Jan - Brugge

Bruges, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU Lille

Lille, 59000, France

RECRUITING

Centre Hospitalo - Univ de Nantes

Nantes, 44000, France

RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

Cliniue Pasteur

Toulouse, 31076, France

RECRUITING

Deutsches Herzzentrum Munchen

Munich, Germany

RECRUITING

University Hospital Ulm

Ulm, Germany

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Brighton and Sussex University Hospital

Brighton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Luc Verhees

CONTACT

+31 6 4270 2457lverhees@highlifemed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 17, 2021

Study Start

July 1, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

February 1, 2031

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations

AU(3)BE(2)DE(2)GB(1)PL(2)FR(4)