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

Primary Purpose

Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HighLife Transcatheter Mitral Valve Replacment
Sponsored by
HighLife SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

  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

    -

Sites / Locations

  • Los Robles Regional Medical CenterRecruiting
  • Piedmont HeartRecruiting
  • Minneapolis HeartRecruiting
  • Montefiore Medical CenterRecruiting
  • University of PennsylvaniaRecruiting
  • Medical University of South CarolinaRecruiting
  • Houston Methodist HospitalRecruiting
  • Chippenham Hospital RichmondRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

Outcomes

Primary Outcome Measures

Device Safety
Freedom from major adverse events

Secondary Outcome Measures

Full Information

First Posted
July 20, 2019
Last Updated
October 21, 2022
Sponsor
HighLife SAS
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1. Study Identification

Unique Protocol Identification Number
NCT04029337
Brief Title
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Official Title
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HighLife SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HighLife Transcatheter Mitral Valve Replacment
Intervention Description
Transcatheter mitral valve replacement
Primary Outcome Measure Information:
Title
Device Safety
Description
Freedom from major adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Facility Information:
Facility Name
Los Robles Regional Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saibal Kar, MD
Phone
805-497-2727
Email
saibalkar60@gmail.com
First Name & Middle Initial & Last Name & Degree
Saibal Kar, MD
Facility Name
Piedmont Heart
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, MD
Phone
404-605-5000
Email
pradeep.yadav@piedmont.org
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, MD
Facility Name
Minneapolis Heart
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Phone
612-863-3900
Email
paul.sorajja@allina.com
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Phone
718-920-4321
Email
mlatib@montefiore.org
First Name & Middle Initial & Last Name & Degree
Azim Latib, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Herrmann, MD
Phone
215-898-5000
Email
howard.herrmann@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Howard Herrmann, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Steinberg, MD
Phone
843-792-1414
Email
steinbe@musc.edu
First Name & Middle Initial & Last Name & Degree
Daniel Steinberg, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Goel, MD
Phone
713-790-3311
Email
ssgoel@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Sachin Goel, MD
Facility Name
Chippenham Hospital Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Lim, MD
Phone
804-483-0000
Email
SL9PC@virginia.edu
First Name & Middle Initial & Last Name & Degree
Scott Lim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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