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

Primary Purpose

Heart Failure, Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V-Wave Shunt Placement
Sponsored by
samir kapadia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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).

a. Clinical eligibility for MitraClip: i. Symptomatic secondary MR (moderate-severe [3+ or 4+] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class III, or ambulatory IV iii. Maximization of GDMT as directed by the "Heart Team", including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction), rhythm disorders, and coronary disease, if applicable

  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.

iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option b. Anatomic eligibility for MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice area > 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in the grasping area vi. In patients with a degenerative component to MR, the following additional criteria must be met:

  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.

Exclusion Criteria:

Preliminary Exclusion Criteria (PEC) - to assessed by the Preliminary Screen at the baseline visit:

  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.

    Final Exclusion Criteria (FEC) - Assessed by the Final Screening, performed at time of cardiac catheterization prior to device placement (Study Intervention Visit)

  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.

    i. IV fluids and medications may be given to support MAP to a goal ≥ 90 mmHg if necessary.

  33. Patient is otherwise not appropriate for study as determined by the Investigator.

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

V-Wave Shunt Placement

Outcomes

Primary Outcome Measures

All-cause death
Number of death caused by any condition
Stroke/paradoxical embolism
Number of patients who developed stroke/paradoxical embolism
Myocardial infarction
Number of patients who developed MI
V-Wave shunt device embolization
Number of V-Wave shunt device embolization occurrence
Cardiac Tamponade
Number of occurrence of cardiac tamponade
Device related re-intervention or surgery
Occurrence of device related re-intervention of surgery

Secondary Outcome Measures

All-cause death
Number of death caused by any condition
Stroke/paradoxical embolism
Number of patients who developed stroke/paradoxical embolism
Myocardial infarction
Number of patients who developed MI
V-Wave shunt device embolization
Number of V-Wave shunt device embolization occurrence
Cardiac Tamponade
Number of occurrence of cardiac tamponade
Device related re-intervention or surgery
Occurrence of device related re-intervention of surgery

Full Information

First Posted
January 25, 2021
Last Updated
May 3, 2023
Sponsor
samir kapadia
Collaborators
V-Wave Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04729933
Brief Title
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
Official Title
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
samir kapadia
Collaborators
V-Wave Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac catheterization which allows for the transfer of blood from the left atrium (LA) to right atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary congestion. All patients in the study must meet all anatomic and clinical eligibility in the FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR). All patients must have persistence of New York Heart Association (NYHA) class III or ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for recurrent HF events and readmission, and thus there is an unmet need for further therapies to improve outcomes in this patient population. The existing transseptal puncture used for MitraClip placement will be used to place the V-Wave Shunt device after MitraClip placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
V-Wave Shunt Placement
Intervention Type
Device
Intervention Name(s)
V-Wave Shunt Placement
Intervention Description
After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
Primary Outcome Measure Information:
Title
All-cause death
Description
Number of death caused by any condition
Time Frame
Up to 1 month post implant
Title
Stroke/paradoxical embolism
Description
Number of patients who developed stroke/paradoxical embolism
Time Frame
Up to 1 month post implant
Title
Myocardial infarction
Description
Number of patients who developed MI
Time Frame
Up to 1 month
Title
V-Wave shunt device embolization
Description
Number of V-Wave shunt device embolization occurrence
Time Frame
Up to 1 month
Title
Cardiac Tamponade
Description
Number of occurrence of cardiac tamponade
Time Frame
Up to 1 month
Title
Device related re-intervention or surgery
Description
Occurrence of device related re-intervention of surgery
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
All-cause death
Description
Number of death caused by any condition
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years
Title
Stroke/paradoxical embolism
Description
Number of patients who developed stroke/paradoxical embolism
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years
Title
Myocardial infarction
Description
Number of patients who developed MI
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years
Title
V-Wave shunt device embolization
Description
Number of V-Wave shunt device embolization occurrence
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years
Title
Cardiac Tamponade
Description
Number of occurrence of cardiac tamponade
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years
Title
Device related re-intervention or surgery
Description
Occurrence of device related re-intervention of surgery
Time Frame
At 6 months, 1 year, 2 years, 3 years and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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). a. Clinical eligibility for MitraClip: i. Symptomatic secondary MR (moderate-severe [3+ or 4+] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class III, or ambulatory IV iii. Maximization of GDMT as directed by the "Heart Team", including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction), rhythm disorders, and coronary disease, if applicable 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) 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. 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. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. Receiving Class I recommended cardiac rhythm management device therapy. 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 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. iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option b. Anatomic eligibility for MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice area > 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in the grasping area vi. In patients with a degenerative component to MR, the following additional criteria must be met: Flail width <15 mm 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. Exclusion Criteria: Preliminary Exclusion Criteria (PEC) - to assessed by the Preliminary Screen at the baseline visit: 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]). 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. Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation. Untreated clinically significant coronary disease requiring revascularization Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days Aortic or tricuspid valve requiring surgery or transcatheter intervention COPD requiring continuous home oxygen therapy or chronic outpatient steroid use Cerebrovascular accident within prior 30 days Known severe symptomatic carotid stenosis Carotid surgery or stenting within prior 30 days ACC/AHA Stage D heart failure Presence of any of the following: 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 Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis) Leaflet anatomy which may preclude MitraClip implantation 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. Need for surgery within 12 months Life expectancy < 1 year due to non-cardiac conditions Status 1 for cardiac transplant or history of cardiac transplant Modified Rankin score ≥ 4 for disability Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) Active infection requiring antibiotic therapy TEE is contraindicated or high risk Pregnant or planning pregnancy within 12 months Known hypersensitivity or contraindication to procedural medications that cannot be adequately treated Known allergy to nickel. Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee, for which the reasons must be documented. 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. Final Exclusion Criteria (FEC) - Assessed by the Final Screening, performed at time of cardiac catheterization prior to device placement (Study Intervention Visit) 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. Anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, including: A posterior rim between the septum secundum and aorta (i.e. aortic rim) of < 5 mm. 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. 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) Key hemodynamic exclusions after MitraClip treatment: Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP must be elevated > 20 mmHg after completion of MitraClip). Difference between mean LAP and mean RAP < 5mmHg after MitraClip placement (i.e. difference between LAP - RAP must be ≥ 5 mmHg). 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. i. IV fluids and medications may be given to support MAP to a goal ≥ 90 mmHg if necessary. Characteristics of septal defect Angle of placement of V-WAVE shunt should be no more than 135 degrees to prevent slippage through the septum, and Septal defect created by MtrraClip delivery system must be 8mm or smaller, in any dimention, without evidence of a tear in the septum Patient is otherwise not appropriate for study as determined by the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Kapadia, M. D.
Phone
216-444-6735
Email
kapadis@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Grant Reed, M. D.
Phone
216-445-7396
Email
reedg2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, M. D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, M. D.
Phone
216-444-6735
Email
kapadis@ccf.org
First Name & Middle Initial & Last Name & Degree
Yuki Kuramochi, BSN, RN
Phone
216-445-4063
Email
kuramoy@ccf.org
First Name & Middle Initial & Last Name & Degree
Grant Reed, M. D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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