Tricuspid Valve InsufficiencyNCT06479824
NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study
A study testing TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) in people with Tricuspid Valve Insufficiency, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
Background: Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2025to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >= 21 years
- Severe tricuspid valve regurgitation with intact tricuspid leaflets, due to annular dilation, leaflet tethering, etc.
- NYHA class III or IV congestive heart failure (symptomatic tricuspid regurgitation)
- Cardiac size suitable for available TRAIPTA study devices according to NHLBI Core Lab analysis of cardiac CTA indicating a TRAIPTA extracardiac perimeter of 25-40cm.
- Concordance of the study central clinical eligibility committee
- Consents to participate, in writing, and willing to comply with all study procedures for the duration of the study
Who cannot join
- Prior cardiac surgery, which may preclude pericardial access, or known pericardial adhesions
- Prior coronary artery stent in the atrioventricular groove
- Severe mitral valve regurgitation assessed by echo
- Left ventricular systolic dysfunction, LVEF < 0.30
- Right atrial pacemaker lead if it might preclude trans-atrial access for TRAIPTA
- Eligible for commercially-available transcatheter tricuspid valve replacement
Show all 15Show fewer
- Eligible for commercially-available tricuspid edge-to-edge repair (TTEER). Recurrent or persistent symptomatic tricuspid regurgitation despite TTEER is not excluded.
- Having transcatheter heart valve implants at risk of compression by TRAIPTA based on anatomic location on pre-procedure CT
- Severe pulmonary artery hypertension, pulmonary artery systolic pressure >=60 mm Hg
- Severe baseline renal excretory dysfunction, eGFR<30mL/min/1.73m^2 unless on renal replacement therapy
- Evidence of thrombus in left atrial appendage on baseline CTA
- Known hypersensitivity to study device materials (for example, nickel)
- Acute coronary syndrome, myocardial infarction, or percutaneous coronary intervention within 30 days
- Requiring other structural heart intervention or coronary revascularization procedure in next 3 months
- Pregnancy or intent to become pregnant prior to completion of all 12-month protocol follow-up procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30308
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
About this study
Background:
Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. The tricuspid is the most difficult valve to repair with surgery. Researchers want to try a new procedure called trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA).
Read more
Objective:
To test TRAIPTA in people with tricuspid valve regurgitation.
Eligibility:
Adults aged 21 years and over with tricuspid valve regurgitation. They must not be eligible for standard surgical repair.
Design:
Participants will be screened. They will have tests of their heart function; these will include blood tests, imaging scans, and a 6-minute walking test.
Participants will enter the hospital for at least 1 day. The TRAIPTA procedure will be done under sedation or general anesthesia. The TRAIPTA study device is a loop that will be placed around the heart like a belt. It acts like a lasso to reduce leakage of the heart valve. Doctors will put the device in place by inserting a wire through a vein in the leg; they will thread the device up to the heart through the vein. The wire will be removed, but the TRAIPTA device will remain in place.
Participants will have follow-up visits 4 times in 1 year after the procedure. These visits will include physical exams, blood tests, imaging scans, and other tests of heart function.
Researchers will contact participants or their doctors for heart test results for another 4 years....
Read the detailed description
Study Description:
Functional tricuspid valve regurgitation is common, has high morbidity and mortality, and has no good treatments. We developed a new transcatheter treatment for this orphan disease called TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty). In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage.
This is the first human test of the TRAIPTA technique. It is offered to patients who are suffering from clinically significant tricuspid valve regurgitation and who have no other good treatment options.
Objectives:
The objectives of this study are to test whether TRAIPTA is feasible, safe, favorably remodels tricuspid annular geometry, and reduces severity of functional tricuspid valve regurgitation.
Primary Safety Endpoint:
The primary endpoint is safety, measured as a composite of freedom from major adverse cardiovascular events (MACE) assessed at 30 days after the TRAIPTA procedure, including all of the following:
- All-cause Mortality
- Stroke (disabling and non-disabling)
- Device-related pulmonary thromboembolism (symptomatic)
- TRAIPTA-related coronary compression requiring coronary revascularization or post-procedure relief of TRAIPTAcompression
- Pericardial tamponade. Note that insertion of a pericardial drain and pericardial effusion requiring drainage is an expected part of the TRAIPTA procedure, and does not contribute to the primary safety endpoint.
- Major cardiac structural related complications including cardiac surgery related to the device.
- Major access site and vascular complications
- Acute kidney injury requiring new renal replacement therapy.
- Bleeding (major or worse) according to MVARC
Secondary (Performance) Endpoints:
The performance endpoints are secondary, and are assessed at the timepoints indicated.
- Technical success (measured at exit from cath lab). All the following must be present:
- Absence of procedural mortality; and
- Successful access, delivery, and retrieval of the TRAIPTA Delivery System; and
- Successful deployment and correct positioning of the TRAIPTA annuloplasty belt; and
- Freedom from emergency surgery or reintervention related to the TRIAPTA or access procedure.
- Device success (measured at 30 days). All of the following must be present:
- Absence of procedural mortality or stroke; and
- Proper placement and positioning of the TRAIPTA annuloplasty belt; and
- Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
- Safety of the TRAIPTA annuloplasty belt, including:
- No evidence of structural or functional device failure
- No specific device-related technical failure issues and complications
- Reduction of TR by at least one degree without significant tricuspid valve stenosis.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)
- Keywords
- Tricuspid Valve Regurgitation, Transcatheter, Circumferential Compressive Implant
- 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.
TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)Device
In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) Receives: Device: TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TRAIPTA procedure
Safety is measured as a composite of freedom from major adverse cardiovascular events (MACE) assessed at 30 days after the TRAIPTA procedure, including all of the following:-All-cause Mortality-Stroke (disabling and non-disabling)-Device-related pulmonary thromboembolism (symptomatic)-TRAIPTA-related coronary compression requiring coronary revascularization or post-procedure relief of TRAIPTA-compression-Pericardial tamponade. Note that insertion of a pericardial drain and pericardial effusion requiring drainage is an expected part of the TRAIPTA procedure, and does not contribute to the primary safety endpoint.-Major cardiac structural related complications including cardiac surgery related to the device.-Major access site and vascular complications-Acute kidney injury requiring new renal replacement therapy.-Bleeding (major or worse) according to MVARC
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start19 Aug 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Why it stopped: Enrollment has been put on hold by the sponsor to allow for further engineering evaluation and performance review of the investigational device, as well as reassessment of the underlying device reliability assumptions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479824
- Sponsor's protocol ID
- 10002050
- Other IDs
- 002050-H
- Status last verified
- 26 Aug 2026
- First submitted
- 27 Jun 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD that underline results in a publication will be shared. Medical images will not be shared because of intrinsic inability to protect confidentiality with reasonable effort.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06479824
- Acronym / sponsor ID
- 10002050
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- Tricuspid Valve Regurgitation, Transcatheter, Circumferential Compressive Implant
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment has been put on hold by the sponsor to allow for further engineering evaluation and performance review of the investigational device, as well as reassessment of the underlying device reliability assumptions.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 28 Jun 2024 (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.
Background:
Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. The tricuspid is the most difficult valve to repair with surgery. Researchers want to try a new procedure called trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA).
Objective:
To test TRAIPTA in people with tricuspid valve regurgitation.
Eligibility:
Adults aged 21 years and over with tricuspid valve regurgitation. They must not be eligible for standard surgical repair.
Design:
Participants will be screened. They will have tests of their heart function; these will include blood tests, imaging scans, and a 6-minute walking test.
Participants will enter the hospital for at least 1 day. The TRAIPTA procedure will be done under sedation or general anesthesia. The TRAIPTA study device is a loop that will be placed around the heart like a belt. It acts like a lasso to reduce leakage of the heart valve. Doctors will put the device in place by inserting a wire through a vein in the leg; they will thread the device up to the heart through the vein. The wire will be removed, but the TRAIPTA device will remain in place.
Participants will have follow-up visits 4 times in 1 year after the procedure. These visits will include physical exams, blood tests, imaging scans, and other tests of heart function.
Researchers will contact participants or their doctors for heart test results for another 4 years....
Detailed description
Study Description:
Functional tricuspid valve regurgitation is common, has high morbidity and mortality, and has no good treatments. We developed a new transcatheter treatment for this orphan disease called TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty). In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage.
This is the first human test of the TRAIPTA technique. It is offered to patients who are suffering from clinically significant tricuspid valve regurgitation and who have no other good treatment options.
Objectives:
The objectives of this study are to test whether TRAIPTA is feasible, safe, favorably remodels tricuspid annular geometry, and reduces severity of functional tricuspid valve regurgitation.
Primary Safety Endpoint:
The primary endpoint is safety, measured as a composite of freedom from major adverse cardiovascular events (MACE) assessed at 30 days after the TRAIPTA procedure, including all of the following:
- All-cause Mortality
- Stroke (disabling and non-disabling)
- Device-related pulmonary thromboembolism (symptomatic)
- TRAIPTA-related coronary compression requiring coronary revascularization or post-procedure relief of TRAIPTAcompression
- Pericardial tamponade. Note that insertion of a pericardial drain and pericardial effusion requiring drainage is an expected part of the TRAIPTA procedure, and does not contribute to the primary safety endpoint.
- Major cardiac structural related complications including cardiac surgery related to the device.
- Major access site and vascular complications
- Acute kidney injury requiring new renal replacement therapy.
- Bleeding (major or worse) according to MVARC
Secondary (Performance) Endpoints:
The performance endpoints are secondary, and are assessed at the timepoints indicated.
- Technical success (measured at exit from cath lab). All the following must be present:
- Absence of procedural mortality; and
- Successful access, delivery, and retrieval of the TRAIPTA Delivery System; and
- Successful deployment and correct positioning of the TRAIPTA annuloplasty belt; and
- Freedom from emergency surgery or reintervention related to the TRIAPTA or access procedure.
- Device success (measured at 30 days). All of the following must be present:
- Absence of procedural mortality or stroke; and
- Proper placement and positioning of the TRAIPTA annuloplasty belt; and
- Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
- Safety of the TRAIPTA annuloplasty belt, including:
- No evidence of structural or functional device failure
- No specific device-related technical failure issues and complications
- Reduction of TR by at least one degree without significant tricuspid valve stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults >= 21 years
- Severe tricuspid valve regurgitation with intact tricuspid leaflets, due to annular dilation, leaflet tethering, etc.
- NYHA class III or IV congestive heart failure (symptomatic tricuspid regurgitation)
- Cardiac size suitable for available TRAIPTA study devices according to NHLBI Core Lab analysis of cardiac CTA indicating a TRAIPTA extracardiac perimeter of 25-40cm.
- Concordance of the study central clinical eligibility committee
Key exclusion criteria (15 listed)
- Prior cardiac surgery, which may preclude pericardial access, or known pericardial adhesions
- Prior coronary artery stent in the atrioventricular groove
- Severe mitral valve regurgitation assessed by echo
- Left ventricular systolic dysfunction, LVEF < 0.30
- Right atrial pacemaker lead if it might preclude trans-atrial access for TRAIPTA
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 |
|---|---|---|
| TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage. | Device | Treatment |
Primary outcome
Safety of TRAIPTA procedure
Time frame: 30 days
Safety is measured as a composite of freedom from major adverse cardiovascular events (MACE) assessed at 30 days after the TRAIPTA procedure, including all of the following:-All-cause Mortality-Stroke (disabling and non-disabling)-Device-related pulmonary thromboembolism (symptomatic)-TRAIPTA-related coronary compression requiring coronary revascularization or post-procedure relief of TRAIPTA-compression-Pericardial tamponade. Note that insertion of a pericardial drain and pericardial effusion requiring drainage is an expected part of the TRAIPTA procedure, and does not contribute to the primary safety endpoint.-Major cardiac structural related complications including cardiac surgery related to the device.-Major access site and vascular complications-Acute kidney injury requiring new renal replacement therapy.-Bleeding (major or worse) according to MVARC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD that underline results in a publication will be shared. Medical images will not be shared because of intrinsic inability to protect confidentiality with reasonable effort.
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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.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) in people with Tricuspid Valve Insufficiency, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 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 6 inclusion and 15 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: paused, as of the sponsor's last update on 15 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 2 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?
Results are not available in the source record.
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?
Safety of TRAIPTA procedure (time frame: 30 days). 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 15 Oct 2026.