Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03611270 · ClinicalTrials.gov registry record · NA
TReatment of Pulmonary Hypertension Group II Study
A NA study of Pulmonary Hypertension (PH) Due to Left Heart Disease, sponsored by SoniVie.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 3
- Study locations
NCT03611270: Active NA study of Pulmonary Hypertension (PH) Due to Left Heart Disease, sponsored by SoniVie.
NCT03611270 is a NA study of Pulmonary Hypertension (PH) Due to Left Heart Disease that is active but no longer recruiting, run by SoniVie. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03611270, a NA study of Pulmonary Hypertension (PH) Due to Left Heart Disease, is active but no longer recruiting, sponsored by SoniVie.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR\>3 wood units.
Primary Outcome
Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.
Conditions Studied
Interventions
- DEVICE Pulmonary Denervation
Study Locations (3)
California
- UC San Diego Medical Center - San Diego
- University of California, San Francisco Medical Center - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2027-07 |
| Phase | NA |
What the registry record for NCT03611270 still lists
NCT03611270 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pulmonary Hypertension (PH) Due to Left Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Pulmonary Denervation is the first listed.
NCT03611270 reports a single indexed study location in California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03611270 about?
NCT03611270 is a clinical study titled "TReatment of Pulmonary Hypertension Group II Study". The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-c...
What is the current status of trial NCT03611270?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2018-11-30. Estimated completion is 2027-07.
What conditions does trial NCT03611270 study?
This clinical trial studies the following conditions: Pulmonary Hypertension (PH) Due to Left Heart Disease.
What interventions are being tested in trial NCT03611270?
The interventions under investigation include: Pulmonary Denervation (DEVICE).
Who is sponsoring clinical trial NCT03611270?
This trial is sponsored by SoniVie, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03611270 being conducted?
This trial has 3 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03611270's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI