Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: sham operationPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6M...
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, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6MWD at 6-month after PADN procedure was 65±85 m. As a result, a total of 128 PAH patients was required, with 64 patients/per group at a ratio of 1:1 randomization.
Tracking Information
- NCT #
- NCT03282266
- Collaborators
- Pulnovo Medical(Wuxi)Co.,Ltd
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital of Zhengzhou University
- Tianjin Medical University General Hospital
- First Affiliated Hospital Xi'an Jiaotong University
- Beijing Anzhen Hospital
- Shenyang Northern Hospital
- The Second Affiliated Hospital of Chongqing Medical University
- Tongji Hospital
- Investigators
- Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University