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
Pulnovo Medical (Wuxi) Co., Ltd.
264 participants
Aug 14, 2023
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
Inclusion Criteria12
- Age ≥18, ≤75 years old;
- Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
- Clinically stable defined by
- No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
- Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg and resting heart rate (HR) ≥50 and \<100 bpm (\<110 bpm for atrial fibrillation) on the day of the procedure
- New York Heart Association (NYHA) class II-IVa;
- MWD ≥ 100 m and \< 450 m;
- NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
- Hemodynamic indicators (RHC) :
- Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
- Pulmonary capillary wedge pressure (PCWP) \>15 mmHg
- Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.
Exclusion Criteria23
- Any of the following:
- Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
- Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
- Untreated congenital heart disease; or
- Have 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 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)
- Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
- Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
- Anticipated to undergo any surgery within 6 months;
- The cardiac index (CI) of RHC \< 1.5L/min/m²;
- Severe renal insufficiency (eGFR \<30mL/min/1.73m² by MDRD formula);
- Severe liver insufficiency (Child-Pugh classification C);
- Platelet count \< 50 × 10\^9/L;
- Life expectancy \<1 year;
- Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
- Active infection requiring oral or intravenous antibiotics;
- Body mass index (BMI) \>40 kg/m²;
- Pregnant or lactating women, or plan to pregnant in one year;
- Participated in other clinical trials within 3 months prior to signing the informed consent;
- Any other circumstances that investigators deem inappropriate to participate in this trial.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05824923