Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER) (HOVER)

Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation HOVER Trial

The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at a very high surgical risk for tricuspid valve replacement.

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava

Detailed Description

This is a prospective multi-center, non-blinded (open label), non-randomized safety and feasibility study of the heterotopic implantation of the Edwards-Sapien XT or S3 valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at a very high surgical risk for tricuspid valve replacement.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients must be at least 21 years old.
2. The patient must have severe, symptomatic (ACC/AHA Stage D symptoms) tricuspid regurgitation (TR) as assessed by 2D echocardiogram with evidence of peripheral and central venous congestion (specifically lower extremity edema and abdominal ascites requiring diuretics.)
3. The patient must be evaluated by a "heart team" of physicians including an interventional cardiologist, cardiothoracic surgeon, heart failure specialist, and imaging specialist, and presented for review at a local multi-disciplinary conference. By consensus, the heart team must agree (and verify in the case review process) that valve implantation will likely benefit the patient.
4. The heart team must agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Also, other factors which may increase the patients perceived surgical risk for inclusion in the trial will be clearly delineated if they are present. These include, but are not limited to the following as defined by VARC 2: Frailty, Hostile chest, porcelain aorta, IMA or other critical conduit crossing the midline or adherent to the posterior table of sternum, severe right ventricular (RV) dysfunction. The surgeons' consultation notes shall specify the medical or anatomic factors leading to that conclusion. At least one of the cardiac surgeon assessors must have interviewed and examined the patient.
5. The study patient provides informed consent and agrees to comply with all required post-procedure follow-up visits, including annual visits up to 5 years.

Exclusion Criteria:

1. Heart Team assessment of operability (the heart team considers the patient to be a good surgical candidate).
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
3. Untreated, severe, left sided valvular heart disease including mitral regurgitation or stenosis, and aortic regurgitation or stenosis.
4. Mean pulmonary artery pressures ≥40mmHG and PVR >4 woods units as assessed by right heart catheterization.
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Examples of permanent implant would include any new heart valve. Implantation of a permanent pacemaker is excluded.
6. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
7. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL).
8. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
9. Need for emergency surgery for any reason.
10. Left ventricular ejection fraction <40%.
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
12. Active upper GI bleeding within 3 months (90 days) prior to procedure.
13. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
14. Recent CVA clinically confirmed (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
15. Estimated life expectancy < 1 year from conditions other than TR.
16. Expectation that patient will not improve despite treatment of tricuspid regurgitation
17. Currently participating in another investigational cardiac device study or any other clinical trial, including drugs or biologics. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
18. Active bacterial endocarditis within 6 months (180 days) of procedure.
19. Patients with signs or symptoms of SVC syndrome, or hepatic cirrhosis not felt due to passive congestion from TR.

20: Subject unable to personally provide informed consent 21. FEV1<30% of predicted 22. Model for End State Liver Disease (MELD) score ≥21 (calculated per reference study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe Tricuspid Regurgitation; This is a non-blinded (open label), non-randomized safety and feasibility study of the heterotopic implantation of the Edwards Sapien 3 valve.	Device: Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success will include both device success and no device/procedure related SAE's including: all death, all stroke, MI, new AKI grade 3, life threatening bleeding, major vascular complications (arterial or venous-requiring unplanned intervention), pericardial effusion or tamponade requiring drainage, SVC syndrome	30 days
Individual patient success	Individual patient success is defined by device success and the following: no re-hospitalizations for right sided heart failure or right sided heart failure equivalents including drainage of ascites or pleural effusions, new listing for heart transplant, VAD, or other mechanical support; improvement in one of three variables: KCCQ improvement>15 vs. baseline; 6MWT improvement> 70 meters vs. baseline; or VO2 peak improvement > 6% vs baseline..	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LE edema	Improvement in LE edema measured by the Villalta Scale	30 days, 6 months, annually to 5 years
Stroke and TIA	Occurrence of stroke or TIA by Valve Academic Research Consortium (VARC-2) criteria	30 days, 6 months, annually to 5 years
Mortality	Death	30 days, 6 months, annually to 5 years
Myocardial Infarction	Occurrence of MI by VARC-2	30 days, 6 months, annually to 5 years
Acute kidney injury	Occurrence of acute kidney injury by VARC-2	30 days, 6 months, annually to 5 years
Major vascular complications	Occurrence of major vascular complications by VARC-2	30 days, 6 months, annually to 5 years
EORTC QLQ-C30	Improvement in Quality of Life questionnaire	30 days, 6 months, annually to 5 years
ESAS-AM	Improvement in Quality of Life questionnaire	30 days, 6 months, annually to 5 years

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Brian P O'Neill, MD, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimated): January 16, 2015

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: G140131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes