Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension

NACompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

January 18, 2018

Primary Completion Date

June 22, 2021

Study Completion Date

December 22, 2021

Conditions
Pulmonary Arterial Hypertension
Interventions
PROCEDURE

PADN

PADN was performed at three sites at the conjunctional area between the distal main trunk and the ostial left branch. The following ablation parameters were programmed at each point: a temperature of 45 ℃-50 ℃, energy ≤15 W, and a time of 120 seconds. The procedure would cease for 10 seconds if the patient felt intolerable chest pain during the procedure. The EKG and pressure lines (including cardiac output) were monitored and continuously recorded throughout the procedure.

PROCEDURE

Sham operation

The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.

Trial Locations (1)

210006

Nanjing First Hospital, Nanjing

All Listed Sponsors
collaborator

Pulnovo Medical (Wuxi) Co., Ltd.

INDUSTRY

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

Tianjin Medical University General Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Beijing Anzhen Hospital

OTHER

collaborator

Shenyang Northern Hospital

OTHER

collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

collaborator

Tongji Hospital

OTHER

lead

Nanjing First Hospital, Nanjing Medical University

OTHER

NCT03282266 - Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter