Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05996562
NA

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.

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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