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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2021-12-22

Brief Summary

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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.

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Detailed Description

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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 patients with Group I PAH are randomized at a ratio of 1:1 to either PADN procedure plus phosphodiesterase-5 inhibitors (PDE5i) group (PADN group) or sham-PADN procedure plus PDE5i group (Sham group) using a randomization schedule blocked by site. The combination therapy of PDE5i with additional other PAH-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

sham operation

Study Groups

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PADN + 5-phosphodiesterase

A total of 64 patients are assigned to PADN + 5-phosphodiesterase group after randomization schedule.

Group Type EXPERIMENTAL

PADN

Intervention Type PROCEDURE

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.

Sham operation + 5-phosphodiesterase

A total of 64 patients are assigned to sham operation + 5-phosphodiesterase group after randomization schedule.

Group Type SHAM_COMPARATOR

Sham operation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Sham operation

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

Intervention Type PROCEDURE

Other Intervention Names

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pulmonary artery denervation

Eligibility Criteria

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Inclusion Criteria

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 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No