NCT05951166Active, not recruiting
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 12 Jun 2023
- Start date
- 5 May 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Gradient Denervation Technologies
- NCT number
- NCT05951166
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 5 May 2023 to the primary completion date, 31 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
Other illness
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Systemic infection or localized infection/rash at planned access site at time of procedure
- CRT or other Interventional cardiac procedure (except RHC) within last 3 months
- Any planned cardiac procedure or inpatient procedure within the next 30 days
Other
- Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
Who the study is looking for
- Heart Failure with EF ≥ 40% (by TTE within last 3 months)
- Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
- Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
- Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
- Cardiac index (CI) ≥ 1.7 L/min/m2
- NYHA Class II or III
- Glomerular Filtration Rate (GFR) ≥ 25 ml/min
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
- Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Age in the registry: 22 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Israeli Georgian Medical Research Clinic Helsicore Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Tbilisi Heart Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.