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

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 objective is to assess effectiveness and safety of PADN for the treatment of PAH.

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.

Sponsors & Collaborators

• Pulnovo Medical (Wuxi) Co., Ltd.

  collaborator INDUSTRY

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Shenyang Northern Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Nanjing First Hospital, Nanjing Medical University

  lead OTHER

Principal Investigators

• Hang Zhang, MD · Nanjing First Hospital, Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-18

Primary Completion

2021-06-22

Completion

2021-12-22

Countries

• China

Study Locations