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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02322840




Registration number
NCT02322840
Ethics application status
Date submitted
31/10/2014
Date registered
23/12/2014
Date last updated
22/04/2024

Titles & IDs
Public title
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Scientific title
An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Secondary ID [1] 0 0
MDT19042TMV002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Twelve TMVR Implant
Treatment: Devices - Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

Experimental: Transcatheter Mitral Valve Replacement (TMVR) Implant - Twelve TMVR Implant


Treatment: Devices: Twelve TMVR Implant
Implantation of the Twelve TMVR System -Apical

Treatment: Devices: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Implant of Intrepid valve -Transfemoral
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Procedural Success (Number of patients with successful TMVR placement)
Timepoint [1] 0 0
Through 5 years
Secondary outcome [2] 0 0
Reduction of MR (Number of patients with a reduction of MR Grade)
Timepoint [2] 0 0
Through 5 years

Eligibility
Key inclusion criteria
Key

- Severe mitral regurgitation (MR Grade 3-4+)

- Symptomatic mitral regurgitation (NYHA Class II-IV)

- Trans-apical access deemed feasible by the treating physician (PILOT only)

- Subjects anatomically suitable for the Intrepid TMVR delivery system including
transfemoral and transseptal access (EFS only)

- Native mitral valve geometry and size compatible with the Twelve TMVR/Intrepid

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <25% (EFS)

- Evidence of intracardiac mass, thrombus, or vegetation

- Prior valve surgery or need for other valve surgery

- Prior stroke within 4 weeks (PILOT) or 90 days (EFS)

- Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)

- Need for coronary revascularization

- History of, or active, endocarditis

- Renal insufficiency (Creatinine > 2.5 mg/dL)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Denmark
State/province [12] 0 0
Copenhagen
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiovascular
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
PILOT:

The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in
very high risk mitral regurgitation patients.

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™
Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in
Patients with Severe, Symptomatic Mitral Regurgitation
Trial website
https://clinicaltrials.gov/ct2/show/NCT02322840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynnett Stahl
Address 0 0
Medtronic
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/ct2/show/NCT02322840