Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479824
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty TRAIPTA Early Feasibility Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty TRAIPTA Early Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 002050-H | None | None | None |