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Cephea Early Feasibility Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05061004
Collaborator
(none)
30
Enrollment
11
Locations
1
Arm
68.1
Anticipated Duration (Months)
2.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cephea Mitral Valve System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cephea Early Feasibility Study
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Treatment of mitral regurgitation with the Cephea Mitral Valve System

Device: Cephea Mitral Valve System
Transcatheter mitral valve replacement

Outcome Measures

Primary Outcome Measures

  1. Primary Safety Endpoint [30 days post implant]

    Freedom from all-cause mortality, which will be assessed at 30 days post implant.

  2. Primary Effectiveness Endpoint [30 days post implant]

    Proportion of subjects with mitral regurgitation less than Grade II will be assessed at 30 days post implant.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048
2 University of California - Davis Medical Center Sacramento California United States 95817
3 Piedmont Heart Institute Atlanta Georgia United States 30309
4 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
5 University of Michigan Ann Arbor Michigan United States 48109
6 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
7 Montefiore Medical Center Bronx New York United States 10467
8 Carolinas Medical Center Charlotte North Carolina United States 28203
9 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
10 The Methodist Hospital Houston Texas United States 77030
11 Institut de Cardiologie de Quebec Quebec Canada G1V 4G5

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Barathi Sethuraman, Abbott Structural Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT05061004
Other Study ID Numbers:
  • ABT-CIP-10354
First Posted:
Sep 29, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 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:
Yes
Additional relevant MeSH terms:
Mitral Valve Insufficiency

Study Results

No Results Posted as of Aug 25, 2022