Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02339974 · ClinicalTrials.gov registry record · Phase 3
Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
A Phase 3 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT02339974: Completed Phase 3 study, sponsored by Henry Ford Health System.
NCT02339974 is a Phase 3 study that has completed, run by Henry Ford Health System. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02339974, a Phase 3 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-01 |
| Est. Completion | 2025-06 |
| Phase | Phase 3 |
What the finished NCT02339974 record still lists
NCT02339974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava is the first listed.
NCT02339974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02339974 about?
NCT02339974 is a clinical study titled "Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)". 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...
What is the current status of trial NCT02339974?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2015-01. Estimated completion is 2025-06.
What interventions are being tested in trial NCT02339974?
The interventions under investigation include: Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava (DEVICE).
Who is sponsoring clinical trial NCT02339974?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02339974's enrollment target sits among peer trials
15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia