RecruitingPhase 3NCT05824923

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

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure


Sponsor

Pulnovo Medical (Wuxi) Co., Ltd.

Enrollment

264 participants

Start Date

Aug 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a procedure called pulmonary artery denervation — which disrupts the nerve signals around the main blood vessel leading to the lungs — can improve symptoms in people who have high blood pressure in their lungs caused by heart failure. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with chronic heart failure for at least 3 months and have been on stable heart failure medications for at least one month - Your blood pressure in the lungs (measured during a heart catheter test) is elevated - You are in New York Heart Association (NYHA) class II–IV (meaning heart failure symptoms affect your daily activity) - You can walk at least 100 metres but less than 450 metres in a 6-minute walk test - Your condition is stable (no IV medications needed recently) **You may NOT be eligible if...** - You have had a heart attack, heart bypass surgery, or a stent placed in the last 6 months - You have had a stroke or mini-stroke in the last 30 days - You have a pacemaker or are expected to need one soon - You have severe heart valve disease or another structural heart condition - You have untreated congenital heart disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPulmonary 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.

DRUGGuideline-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.


Locations(1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

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NCT05824923


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