4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Cephea Transseptal Mitral Valve System FIH

Cephea Transseptal Mitral Valve System FIH

Study Description
Brief Summary:
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: Transcatheter Mitral Valve Replacement via Transseptal Access Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cephea Mitral Valve and Transseptal Delivery System FIH
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Transcatheter Mitral Valve Replacement
Replacement valve delivered through a transfemoral access and transseptal approach
 Device: Transcatheter Mitral Valve Replacement via Transseptal Access
The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.
Outcome Measures
Primary Outcome Measures :
  1. Safety as measured by freedom from major adverse events [ Time Frame: 30 days ]

    Freedom from major adverse events, including:

    • All-cause mortality
    • Disabling stroke
    • Myocardial infarction
    • Renal failure requiring dialysis
    • Life-threatening bleeding
    • Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.

  2. Performance [ Time Frame: 30 days ]
    Reduction in mitral regurgitation to ≤1+


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
MVARC
Contacts and Locations

Locations
Layout table for location information
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia
Sponsors and Collaborators
Cephea Valve Technologies
Investigators
Layout table for investigator information
Study Director: Helen J Scotch Cephea Valve Technologies
Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Safety as measured by freedom from major adverse events [ Time Frame: 30 days ]
    Freedom from major adverse events, including:
    • All-cause mortality
    • Disabling stroke
    • Myocardial infarction
    • Renal failure requiring dialysis
    • Life-threatening bleeding
    • Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
  • Performance [ Time Frame: 30 days ]
    Reduction in mitral regurgitation to ≤1+
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cephea Transseptal Mitral Valve System FIH
Official Title  ICMJE Cephea Mitral Valve and Transseptal Delivery System FIH
Brief Summary To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Regurgitation
Intervention  ICMJE Device: Transcatheter Mitral Valve Replacement via Transseptal Access
The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.
Study Arms  ICMJE Experimental: Transcatheter Mitral Valve Replacement
Replacement valve delivered through a transfemoral access and transseptal approach
Intervention: Device: Transcatheter Mitral Valve Replacement via Transseptal Access
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2020) 		1
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		15
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE MVARC
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988946
Other Study ID Numbers  ICMJE CP21549
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cephea Valve Technologies
Study Sponsor  ICMJE Cephea Valve Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Helen J Scotch Cephea Valve Technologies
PRS Account Cephea Valve Technologies
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯