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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 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. The trial reports 3 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03611270
The ClinicalTrials.gov registry entry for NCT03611270 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SoniVie, which has 3 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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