ACTIVE_NOT_RECRUITING

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.

Official Title

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study

Quick Facts

Study Start:2021-03-11

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04729933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. All patients must meet clinical and anatomic eligibility for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU). 1. An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB) 2. Other medications recommended for selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines. 3. Patient has been on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods. 4. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. 5. Receiving Class I recommended cardiac rhythm management device therapy. 1. If indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to device implantation 2. These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator. 1. Flail width \<15 mm 2. Flail gap \<10 mm vii. The primary regurgitant jet is non-commissural, and in the opinion of the implanting investigator can be successfully be treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant) viii. Transseptal catheterization and femoral vein access is feasible per investigator 2. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.	1. Severe pulmonary hypertension, defined as RV systolic pressure or PA systolic pressure \> 70 mmHg, or PVR \> 4 Woods units, measured by any modality (TTE, TEE, cardiac MRI, or pulmonary artery catheterization \[if data available\]). 2. Moderate or severe RV dysfunction defined as TAPSE \<12mm or RVFAC ≤25% as assessed on Baseline TTE, or qualitative assessment of severe RV dysfunction on TTE, TEE, or cardiac MRI. 3. Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation. 4. Untreated clinically significant coronary disease requiring revascularization 5. Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days 6. Aortic or tricuspid valve requiring surgery or transcatheter intervention 7. COPD requiring continuous home oxygen therapy or chronic outpatient steroid use 8. Cerebrovascular accident within prior 30 days 9. Known severe symptomatic carotid stenosis 10. Carotid surgery or stenting within prior 30 days 11. ACC/AHA Stage D heart failure 12. Presence of any of the following: 1. Hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology 2. Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis) 13. Leaflet anatomy which may preclude MitraClip implantation 14. Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 15. Need for surgery within 12 months 16. Life expectancy \< 1 year due to non-cardiac conditions 17. Status 1 for cardiac transplant or history of cardiac transplant 18. Modified Rankin score ≥ 4 for disability 19. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure 20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation 21. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) 22. Active infection requiring antibiotic therapy 23. TEE is contraindicated or high risk 24. Pregnant or planning pregnancy within 12 months 25. Known hypersensitivity or contraindication to procedural medications that cannot be adequately treated 26. Known allergy to nickel. 27. Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee, for which the reasons must be documented. 28. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. 29. Presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement with pulmonary artery catheterization prior to MitraClip placement, defined as PA systolic pressure \> 70 mmHg or PVR \> 4 Woods units. 30. Anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, including: 1. A posterior rim between the septum secundum and aorta (i.e. aortic rim) of \< 5 mm. 2. Atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm. 31. Moderate or worse MR ≥2+ at the end of MitraClip treatment (i.e. MR must be \<2+ by TTE, TEE, invasive hemodynamics, or left ventriculography) 32. Key hemodynamic exclusions after MitraClip treatment: 1. Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP must be elevated \> 20 mmHg after completion of MitraClip). 2. Difference between mean LAP and mean RAP \< 5mmHg after MitraClip placement (i.e. difference between LAP - RAP must be ≥ 5 mmHg). 3. If the patient meets these hemodynamic exclusion criteria and mean arterial pressure (MAP) is \< 90 mmHg, the MAP may be increased to ≥ 90 mmHg and repeat pressure measurements obtained in order to evaluate eligibility. 33. Characteristics of septal defect 1. Angle of placement of V-WAVE shunt should be no more than 135 degrees to prevent slippage through the septum, and 2. Septal defect created by MtrraClip delivery system must be 8mm or smaller, in any dimention, without evidence of a tear in the septum 34. Patient is otherwise not appropriate for study as determined by the Investigator.

Inclusion Criteria

Exclusion Criteria

1. All patients must meet clinical and anatomic eligibility for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU).
1. An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB)
2. Other medications recommended for selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines.
3. Patient has been on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods.
4. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator.
5. Receiving Class I recommended cardiac rhythm management device therapy.
1. If indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to device implantation
2. These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator.
1. Flail width \<15 mm
2. Flail gap \<10 mm vii. The primary regurgitant jet is non-commissural, and in the opinion of the implanting investigator can be successfully be treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant) viii. Transseptal catheterization and femoral vein access is feasible per investigator 2. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.

1. Severe pulmonary hypertension, defined as RV systolic pressure or PA systolic pressure \> 70 mmHg, or PVR \> 4 Woods units, measured by any modality (TTE, TEE, cardiac MRI, or pulmonary artery catheterization \[if data available\]).
2. Moderate or severe RV dysfunction defined as TAPSE \<12mm or RVFAC ≤25% as assessed on Baseline TTE, or qualitative assessment of severe RV dysfunction on TTE, TEE, or cardiac MRI.
3. Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation.
4. Untreated clinically significant coronary disease requiring revascularization
5. Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days
6. Aortic or tricuspid valve requiring surgery or transcatheter intervention
7. COPD requiring continuous home oxygen therapy or chronic outpatient steroid use
8. Cerebrovascular accident within prior 30 days
9. Known severe symptomatic carotid stenosis
10. Carotid surgery or stenting within prior 30 days
11. ACC/AHA Stage D heart failure
12. Presence of any of the following:
1. Hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
2. Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis)
13. Leaflet anatomy which may preclude MitraClip implantation
14. Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
15. Need for surgery within 12 months
16. Life expectancy \< 1 year due to non-cardiac conditions
17. Status 1 for cardiac transplant or history of cardiac transplant
18. Modified Rankin score ≥ 4 for disability
19. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
21. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
22. Active infection requiring antibiotic therapy
23. TEE is contraindicated or high risk
24. Pregnant or planning pregnancy within 12 months
25. Known hypersensitivity or contraindication to procedural medications that cannot be adequately treated
26. Known allergy to nickel.
27. Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee, for which the reasons must be documented.
28. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
29. Presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement with pulmonary artery catheterization prior to MitraClip placement, defined as PA systolic pressure \> 70 mmHg or PVR \> 4 Woods units.
30. Anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, including:
1. A posterior rim between the septum secundum and aorta (i.e. aortic rim) of \< 5 mm.
2. Atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm.
31. Moderate or worse MR ≥2+ at the end of MitraClip treatment (i.e. MR must be \<2+ by TTE, TEE, invasive hemodynamics, or left ventriculography)
32. Key hemodynamic exclusions after MitraClip treatment:
1. Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP must be elevated \> 20 mmHg after completion of MitraClip).
2. Difference between mean LAP and mean RAP \< 5mmHg after MitraClip placement (i.e. difference between LAP - RAP must be ≥ 5 mmHg).
3. If the patient meets these hemodynamic exclusion criteria and mean arterial pressure (MAP) is \< 90 mmHg, the MAP may be increased to ≥ 90 mmHg and repeat pressure measurements obtained in order to evaluate eligibility.
33. Characteristics of septal defect
1. Angle of placement of V-WAVE shunt should be no more than 135 degrees to prevent slippage through the septum, and
2. Septal defect created by MtrraClip delivery system must be 8mm or smaller, in any dimention, without evidence of a tear in the septum
34. Patient is otherwise not appropriate for study as determined by the Investigator.

Contacts and Locations

Principal Investigator

Samir Kapadia, M. D.

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: samir kapadia

Samir Kapadia, M. D., PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-11

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-03-11

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure
Mitral Regurgitation