Tricuspid RegurgitationNCT04433065
TTVR Early Feasibility Study
A study testing Intrepid™ TTVR System in people with Tricuspid Regurgitation, run by Medtronic Cardiovascular at 20 sites in United States.
Trial summary
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Intrepid™ TTVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesUnited States
- Study dates
- 20 Oct 2020to 26 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Who cannot join
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- Echocardiographic evidence of severe right ventricular dysfunction
- Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure
Show all 9Show fewer
- Need for emergent or urgent surgery
- Untreated clinically significant coronary artery disease requiring revascularization
- Carcinoid tricuspid regurgitation
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital Midtown
Atlanta, Georgia, 30308
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
The Christ Hospital
Cincinnati, Ohio, 45242
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Corewell Health
Grand Rapids, Michigan, 49503
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist Hospital
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, 53125
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Providence Saint Patrick Hospital
Missoula, Montana, 59802
The Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
Oregon Health & Science University Hospital
Portland, Oregon, 97239
California Pacific Medical Center
San Francisco, California, 94115
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Read the detailed description
Multi-center, prospective, non-randomized, investigational, and pre-market.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Intrepid™ TTVR System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrepid™ TTVR SystemDevice
Device: Intrepid™ TTVR System
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Experimental | Device: Intrepid TTVR System Receives: Device: Intrepid™ TTVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of implant or delivery related serious adverse events
Rate of implant or delivery related serious adverse events
Measured: Through 30 days post-procedure
Secondary outcomes (4)
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
Measured: During Procedure
Change in TR Grade from baseline
Change in TR Grade from baseline
Measured: Through 30 days post-procedure
Rate of no significant TV stenosis
Rate of no significant TV stenosis
Measured: Through 30 days post-procedure
Change in NYHA Class from baseline
Change in NYHA Class from baseline
Measured: Through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Oct 2020
- Primary completion31 Aug 2026
- Study completion26 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433065
- Sponsor's protocol ID
- MDT20009TMV003
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
- ClinicalTrials.gov ID
- NCT04433065
- Acronym / sponsor ID
- MDT20009TMV003
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 26 Aug 2031 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Detailed description
Multi-center, prospective, non-randomized, investigational, and pre-market.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | Experimental | Device: Intrepid™ TTVR SystemDevice: Intrepid TTVR System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
Key exclusion criteria (9 listed)
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- Echocardiographic evidence of severe right ventricular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrepid™ TTVR SystemDevice: Intrepid™ TTVR System | Device | Primary Cohort |
Primary outcome
Rate of implant or delivery related serious adverse events
Time frame: Through 30 days post-procedure
Rate of implant or delivery related serious adverse events
4 secondary outcomes
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
Time frame: During Procedure
Change in TR Grade from baseline
Time frame: Through 30 days post-procedure
Rate of no significant TV stenosis
Time frame: Through 30 days post-procedure
Change in NYHA Class from baseline
Time frame: Through 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrepid™ TTVR System in people with Tricuspid Regurgitation, run by Medtronic Cardiovascular at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of implant or delivery related serious adverse events (time frame: Through 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.