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Cephea Early Feasibility Study

Primary Purpose

Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cephea Mitral Valve System
Sponsored by
Abbott Medical Devices
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

Key Inclusion Criteria:

  • Mitral regurgitation ≥ Grade III per American Society of Echocardiography criteria.
  • LVEF ≥ 30%
  • In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Key Exclusion Criteria:

  • Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  • Need for emergent or urgent surgery.

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting
  • University of California - Davis Medical CenterRecruiting
  • Piedmont Heart InstituteRecruiting
  • Cardiovascular Research Institute of KansasRecruiting
  • University of MichiganRecruiting
  • Minneapolis Heart InstituteRecruiting
  • Montefiore Medical CenterRecruiting
  • Carolinas Medical CenterRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • St. Thomas HospitalRecruiting
  • The Methodist HospitalRecruiting
  • Sentara Norfolk General Hospital
  • Institut de Cardiologie de MontrealRecruiting
  • Institut de Cardiologie de QuebecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment of mitral regurgitation with the Cephea Mitral Valve System

Outcomes

Primary Outcome Measures

Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Primary Effectiveness Endpoint
Proportion of subjects with mitral regurgitation less than Grade II will be assessed at 30 days post implant.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2021
Last Updated
August 25, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05061004
Brief Title
Cephea Early Feasibility Study
Official Title
Cephea Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral regurgitation ≥ Grade III in whom transcatheter therapy is deemed more appropriate than open heart surgery.

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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation with the Cephea Mitral Valve System
Intervention Type
Device
Intervention Name(s)
Cephea Mitral Valve System
Intervention Description
Transcatheter mitral valve replacement
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Time Frame
30 days post implant
Title
Primary Effectiveness Endpoint
Description
Proportion of subjects with mitral regurgitation less than Grade II will be assessed at 30 days post implant.
Time Frame
30 days post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Mitral regurgitation ≥ Grade III per American Society of Echocardiography criteria. LVEF ≥ 30% In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery. Key Exclusion Criteria: Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. Need for emergent or urgent surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimako Nakajima
Phone
+1 408-845-0873
Email
shimako.nakajima@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barathi Sethuraman
Organizational Affiliation
Abbott Structural Heart
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitch Gheorghiu
Phone
310-423-6152
Email
mitch.gheorghiu@cshs.org
First Name & Middle Initial & Last Name & Degree
Raj Makkar
Facility Name
University of California - Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaelyn Tuermer-Lee
Phone
916-734-5155
Email
ktuermerlee@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Jason Rogers
Facility Name
Piedmont Heart Institute
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
Danielle Griffith
Phone
404-605-2958
Email
Danielle.griffith@piedmont.org
First Name & Middle Initial & Last Name & Degree
Vinod Thourani
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Steele
Phone
316-219-4125
Email
lindsey.steele@cckheart.com
First Name & Middle Initial & Last Name & Degree
Bassem Chehab
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Soave
Phone
734-232-4592
Email
soavek@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi
Facility Name
Minneapolis Heart Institute
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
Jennifer Nguyen
Phone
612-863-9291
Email
Jennifer.nguyen@allina.com
First Name & Middle Initial & Last Name & Degree
Mario Goessl
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Booth
Phone
718-920-6523
Email
kbooth@montefiore.org
First Name & Middle Initial & Last Name & Degree
Mohamed Azeem Latib
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montana Bright
Email
montana.bright@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Michael Rinaldi
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Tylicki
Phone
216-444-6950
Email
tylicke@ccf.org
First Name & Middle Initial & Last Name & Degree
Samir Kapadia
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kolie Gasaway
Phone
615-222-3227
Email
nikole.minnick@ascension.org
First Name & Middle Initial & Last Name & Degree
Evelio Rodriguez
Facility Name
The 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
Deena Victor
Email
dcvictor@HoustonMethodist.org
First Name & Middle Initial & Last Name & Degree
Sachin Goel
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Withdrawn
Facility Name
Institut de Cardiologie de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Moisan
Phone
514-376-3330
Email
natasha.moisan@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Anita Asgar
Facility Name
Institut de Cardiologie de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Lachance
Phone
418-656-8711
Email
dominique.lachance@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau

12. IPD Sharing Statement

Plan to Share IPD
No

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Cephea Early Feasibility Study

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