Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)
![]() |
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03242642 |
Recruitment Status :
Recruiting
First Posted : August 8, 2017
Last Update Posted : December 10, 2021
|
Sponsor:
Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular
Tracking Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | August 3, 2017 | |||||||||
First Posted Date ICMJE | August 8, 2017 | |||||||||
Last Update Posted Date | December 10, 2021 | |||||||||
Actual Study Start Date ICMJE | October 23, 2017 | |||||||||
Estimated Primary Completion Date | October 2023 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
|
|||||||||
Original Primary Outcome Measures ICMJE | Not Provided | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||
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 | Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation | |||||||||
Official Title ICMJE | Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial | |||||||||
Brief Summary | Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||
Condition ICMJE | Mitral Valve Regurgitation | |||||||||
Intervention ICMJE |
|
|||||||||
Study Arms ICMJE |
|
|||||||||
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 | Recruiting | |||||||||
Estimated Enrollment ICMJE |
1350 | |||||||||
Original Enrollment ICMJE | Not Provided | |||||||||
Estimated Study Completion Date ICMJE | October 2028 | |||||||||
Estimated Primary Completion Date | October 2023 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
Sex/Gender ICMJE |
|
|||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE |
|
|||||||||
Listed Location Countries ICMJE | Denmark, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03242642 | |||||||||
Other Study ID Numbers ICMJE | MDT17022TMV001 | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product |
|
|||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Medtronic Cardiovascular | |||||||||
Study Sponsor ICMJE | Medtronic Cardiovascular | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
|
|||||||||
PRS Account | Medtronic Cardiovascular | |||||||||
Verification Date | December 2021 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |