An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Sponsor

HighLife SAS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04029337

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation	Device: HighLife Transcatheter Mitral Valve Replacment	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

Device Safety [30 days]
Freedom from major adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (> 3+)
For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR ≥ moderate-severe or severe by ASE criteria) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. 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 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HighLife SAS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HighLife SAS

ClinicalTrials.gov Identifier:

NCT04029337

Other Study ID Numbers:

HL-2019-01

First Posted:

Jul 23, 2019

Last Update Posted:

Jan 14, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Study Results

No Results Posted as of Jan 14, 2020