Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure（PADN-CpcPH-PILOT）

NCT05996562 | Completed

• 1 other identifier: Pulnovo-CO-2023-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure. Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.

Conditions

Pulmonary Hypertension; Heart Failure

Keywords

Pulmonary Artery Denervation; PADN; Pulmonary Hypertension; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 6-minute walk distance (6MWD) difference

  The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.

  6 months

Study Arms (1)

Pulmonary Artery Denervation (PADN)

EXPERIMENTAL

Procedure: Pulmonary Artery Denervation

Interventions

Pulmonary Artery Denervation PROCEDURE

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°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.

Pulmonary Artery Denervation (PADN)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, ≤85 years;
• PH must be confirmed by RHC, defined as:
• Mean pulmonary arterial pressure (mPAP) \>20mmHg, and;
• Pulmonary capillary wedge pressure (PCWP) \>15mmHg, and；
• Pulmonary vascular resistance (PVR) \> 2WU.
• Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;
• Clinically stable HF for at least 1 month, defined as:
• No need of intravenous diuretics, inotropes or vasodilators, and
• Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg, and
• Resting heart rate (HR) ≥ 50 bpm and \<100 bpm (\>110 bpm in presence of atrial fibrillation) on the day of the procedure.
• NYHA class II-IVa;
• MWD ≥ 100 m and ≤ 450 m;
• NT-proBNP \>125pg/mL (or BNP \> 35pg/mL);
• Understand and be willing to sign informed consent and be strictly willing to follow the protocol.

You may not qualify if:

• Any of the following:
• Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
• Pericardial disease; or
• Infiltrative or inflammatory myocardial disease; or
• Valvular heart disease with stenosis or with severe regurgitation; or
• Active endocarditis; or
• Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
• Congenital heart disease; or
• Having received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
• Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted less than 6 months or are anticipated to be implanted within 6 months; or
• Anticipated to undergo ablation of atrial fibrillation within 6 months; or
• Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
• Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)
• Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
• Anticipated to undergo any surgery within the next 6 months;

Sponsors & Collaborators

• Pulnovo Medical (Wuxi) Co., Ltd.: lead

Study Sites (1)

Hospital de Santa Marta

Lisbon, Portugal

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 18, 2023
• Study Start: June 28, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

PT (1)