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Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Sponsor
HighLife SAS (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04029363
Collaborator
MedPass International (Industry)
50
Enrollment
40
Locations
1
Arm
100.1
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Condition or Disease Intervention/Treatment Phase
  • Device: HighLife Transcatheter Mitral Valve Replacement
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
Actual Study Start Date :
May 28, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Single arm

Single arm, non-randomized

Device: HighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement

Outcome Measures

Primary Outcome Measures

  1. 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:
No
Inclusion Criteria:
    1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 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
  1. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent
Exclusion Criteria:

  1. Any stroke/TIA within 30 days

  2. Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)

  3. Active infections requiring antibiotic therapy

  4. Active ulcer or gastro-intestinal bleeding in the past 3 months

  5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion

  6. Patients in whom TEE is not feasible

  7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.

  8. Patient is unable to comply with the follow-up schedule and assessments

  9. Participation in another clinical investigation at the time of inclusion

  10. Patient has known allergies to the device components or contrast medium

  11. Patient cannot tolerate anticoagulation or antiplatelet therapy

  12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions

  13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Vincent's Hospital - Sydney Darlinghurst New South Wales Australia 2010
2 Macquarie University Hospital Sydney New South Wales Australia 2109
3 The Wesley Hospital Auchenflower Queensland Australia 4066
4 St. Andrew's Hospital Adelaide Australia 5000
5 Warringal Hospital Heidelberg Australia 3084
6 The Alfred Hospital Melbourne Australia 3004
7 Mount Hospital Perth Australia 6150
8 North Shore Private Hospital Sydney Australia
9 ZNA Middelheim Antwerp Belgium 2020
10 AZ Sint-Jan Brugge Belgium 8000
11 UZ Leuven Leuven Belgium 3000
12 CHU Lille Lille France
13 Hopital Prive - Jacques Cartier Massy France
14 Centre Hospitalo-Universitaire de Nantes Nantes France
15 European Hospital George Pompidou Paris France 5015
16 CHU Bordeaux Pessac France 33600
17 CHU de Rennes Rennes France 35000
18 Centr Cardiologiqque du Nord St. Denis France
19 Clinque Pasteur Toulouse France 31076
20 University Heart Center Freiburg - Bad Krozingen Bad Krozingen Germany 79189
21 Universitaetsklinikum Bonn Bonn Germany 53127
22 Heart Center, University Hospital Dresden Dresden Germany
23 Universitatsklink Hamburg-Eppendorf Hamburg Germany 20246
24 University Hospital Heidelberg Heidelberg Germany
25 Herzentrum Leipzig Leipzig Germany 04289
26 Deutsches Herzzentrum Munchen Munich Germany
27 University Medicine Dept of Cardiology Rostock Germany
28 University Hospital Ulm Ulm Germany 89081
29 Medical University of Silesia Hospital Katowice Poland 40-635
30 University Hospital of Lord's Transfiguration Poznan Poland 61-848
31 Medical University of Warsaw Warsaw Poland 02-097
32 Institute of Cardiology Warsaw Poland 04-628
33 Royal Victoria Hospital Belfast United Kingdom
34 Brighton and Sussex University Hospital Brighton United Kingdom BN2 5BE
35 Royal Infirmary of Edinburgh Edinburgh United Kingdom
36 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom
37 University Hospitals of Leicester NHS Trust Leicester United Kingdom
38 Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital London United Kingdom SE1 9RS
39 Barts Heart Center London United Kingdom
40 John Radcliffe Oxford United Kingdom

Sponsors and Collaborators

  • HighLife SAS
  • MedPass International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HighLife SAS
ClinicalTrials.gov Identifier:
NCT04029363
Other Study ID Numbers:
  • HL-2018-01-TS Feasibility
First Posted:
Jul 23, 2019
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Mitral Valve Insufficiency

Study Results

No Results Posted as of Jun 22, 2022