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

NCT02339974 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: G140131
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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. Safety as defined by successful vascular access without unplanned major vascular complication as defined by VARC-2, delivery and retrieval of the transcatheter valve delivery system, correct position of both the vascular stent(s) and transcatheter valve in the IVC, a single valve placed within the IVC, and no need for additional surgery or re-intervention (including drainage of pericardial effusion) with the patient being alive at 30-days.

  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 Outcomes (6)

• Lower Extremity Edema

  30 days, 6 months, 1 Year

• Stroke and Transient Ischemic Attack (TIA)

  30 days, 6 months, 1 year

• Mortality

  30 days, 6 months, 1 year

• Myocardial Infarction

  30 days, 6 months, 1 Year

• Acute Kidney Injury

  30 days, 6 months, 1 Year

Study Arms (1)

Severe Tricuspid Regurgitation

EXPERIMENTAL

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

Interventions

Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava DEVICE

Severe Tricuspid Regurgitation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 21 years old.
• 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.)
• 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.
• 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.

You may not qualify if:

• Heart Team assessment of operability (the heart team considers the patient to be a good surgical candidate).
• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
• Untreated, severe, left sided valvular heart disease including mitral regurgitation or stenosis, and aortic regurgitation or stenosis.
• Mean pulmonary artery pressures ≥40mmHG and PVR \>4 woods units as assessed by right heart catheterization.
• 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.
• Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
• Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt \< 50,000 cell/mL).
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
• Need for emergency surgery for any reason.
• Left ventricular ejection fraction \<40%.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active upper GI bleeding within 3 months (90 days) prior to procedure.
• A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
• Recent CVA clinically confirmed (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
• Estimated life expectancy \< 1 year from conditions other than TR.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hosptial

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This was an early feasibility study. The study did not achieve its intended enrollment of patients.

Results Point of Contact

• Title: Dr. Brian O'Neill
• Organization: Henry Ford Health

boneil3@hfhs.org

313-970-6483

Study Officials

• Brian P O'Neill, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 18, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)