Status:
COMPLETED
Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Collaborating Sponsors:
Pulnovo Medical (Wuxi) Co., Ltd.
Guangdong Provincial People's Hospital
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary obj...
Detailed Description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6MWD) of PADN on PAH patients. Based on the previous studies, t...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures; Men and women 18 years and older; Group I PAH, defined as a mPAP≥25mmHg, PCWP\<15mmHg and PVR\[The PVR =(mPAP-PCWP)/CO\]\>3.0 Woods unit.
Exclusion
- General exclusion criteria:
- Pregnancy and breast feeding mother; Estimated life expectancy \< 12 months; Scheduled major surgery in the next 6 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.
- Procedural exclusion criteria:
- WHO group II, III, IV, V PH Severe Renal dysfunction (Ccr\<30 ml/min) Blood platelet count\<100,000/L Expected life span\<6-month Systematical inflammation Malignant cancer(s) Tricuspid valve stenosis, Supra-pulmonary valve stenosis Allergic to studied drugs or metal materials.
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03282266
Start Date
January 18 2018
End Date
December 22 2021
Last Update
October 3 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006