Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure(PADN-CpcPH-PILOT)
Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
Summary
The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure. Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.
Official title: Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-06-28
Completion Date
2026-01-15
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Pulmonary Artery Denervation
Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.
Locations (7)
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, K'alak'i T'bilisi, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, Georgia
Tbilisi Heart Center
Tbilisi, K'alak'i T'bilisi, Georgia
Ospedale P. Pederzoli
Peschiera del Garda, Verona, Italy
Sarawak Heart Centre
Kota Samarahan, Sarawak, Malaysia
Hospital de Santa Marta
Lisbon, Portugal
National Heart Centre Singapore
Singapore, Singapore, Singapore