A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

PHASE3RecruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

August 14, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

February 28, 2027

Conditions
Pulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction
Interventions
PROCEDURE

Pulmonary arterial denervation

"Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA.~The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.~For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician."

DRUG

Guideline-directed medical therapy (GDMT) for heart failure

"GDMT medication recommendation including:~* Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI)~* Beta-receptor blocker (BB)~* Mineralocorticoid receptor antagonist (MRA)~* Sodium-glucose co-transporter 2 (SGLT2) inhibitor~* Diuretics~The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion."

Trial Locations (1)

Unknown

RECRUITING

General Hospital of Northern Theater Command, Shenyang

All Listed Sponsors
collaborator

The General Hospital of Northern Theater Command

OTHER

collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

collaborator

First Hospital of Tsinghua University

OTHER

collaborator

Cangzhou Central Hospital

OTHER

collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Second Hospital of Jilin University

OTHER

collaborator

China-Japan Union Hospital, Jilin University

OTHER

collaborator

Shanxi Cardiovascular Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Shanghai 10th People's Hospital

OTHER

collaborator

Beijing Anzhen Hospital

OTHER

collaborator

West China Hospital

OTHER

collaborator

Sichuan Academy of Medical Sciences

OTHER

collaborator

The First Affiliated Hospital of Soochow University

OTHER

collaborator

TEDA International Cardiovascular Hospital

OTHER

collaborator

Tianjin Medical University General Hospital

OTHER

collaborator

Renmin Hospital of Wuhan University

OTHER

collaborator

Zhongnan Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Xiamen Cardiovascular Hospital, Xiamen University

OTHER

collaborator

Zhejiang University

OTHER

collaborator

Shengjing Hospital

OTHER

collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Gansu Provincial Hospital

OTHER

collaborator

Yanan Hospital of Kunming City

UNKNOWN

collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

collaborator

Huaihe Hospital of Henan University

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

collaborator

Hunan Provincial People's Hospital

OTHER

collaborator

Tianjin Medical University Second Hospital

OTHER

collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

The First Hospital of Jilin University

OTHER

lead

Pulnovo Medical (Wuxi) Co., Ltd.

INDUSTRY