Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03988946




Registration number
NCT03988946
Ethics application status
Date submitted
10/01/2019
Date registered
18/06/2019
Date last updated
23/01/2020

Titles & IDs
Public title
Cephea Transseptal Mitral Valve System FIH
Scientific title
Cephea Mitral Valve and Transseptal Delivery System FIH
Secondary ID [1] 0 0
CP21549
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcatheter Mitral Valve Replacement via Transseptal Access

Experimental: Transcatheter Mitral Valve Replacement - Replacement valve delivered through a transfemoral access and transseptal approach


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as measured by freedom from major adverse events
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Performance
Timepoint [2] 0 0
30 days

Eligibility
Key inclusion criteria
MVARC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cephea Valve Technologies
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03988946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen J Scotch
Address 0 0
Cephea Valve Technologies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03988946