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
Overview
- Phase
- Phase 3
- Intervention
- Pulmonary arterial denervation
- Conditions
- Pulmonary Hypertension
- Sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Clinical Worsening, defined as the occurrence of any of the followings:
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
Chronic heart failure (CHF) patients who have received guideline-directed medical therapy (GDMT) based on the 2023 ESC Guidelines for HF and have reached clinical stable, and diagnosed with PH-LHD by right heart catheterization, will be randomized to the PADN group or control group in a 1:1 ratio to receive PADN combined with HF GDMT or HF GDMT, respectively. After the 12-month follow-up visit is completed, participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN. Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years. The safety and efficacy of the PADN system, including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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;
- •6MWD ≥ 100 m and \< 450 m;
- •NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
- •Hemodynamic indicators (RHC) :
- •Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
Exclusion Criteria
- •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;
Arms & Interventions
Pulmonary Artery Denervation (PADN)
Patients in the PADN group will receive pulmonary artery denervation procedure.
Intervention: Pulmonary arterial denervation
Pulmonary Artery Denervation (PADN)
Patients in the PADN group will receive pulmonary artery denervation procedure.
Intervention: Guideline-directed medical therapy (GDMT) for heart failure
Guideline-directed medical therapy (GDMT) for heart failure
Patients in the control group will take their baseline anti-heart failure medications at the original doses according to 2023 ESC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.
Intervention: Guideline-directed medical therapy (GDMT) for heart failure
Outcomes
Primary Outcomes
Clinical Worsening, defined as the occurrence of any of the followings:
Time Frame: immediately after the randomization to the last enrolled subject having at least 6 months follow-up
1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death
Secondary Outcomes
- Parameters measured by transthoracic echocardiography(TTE)(6 months, 1 year, 3 years)
- Intravenous medication due to worsening of heart failure(1 month, 6 months, 1 year, 2 years, 3 years)
- Rehospitalization due to heart failure(1 month, 6 months, 1 year, 2 years, 3 years)
- N-terminal pro-B-type natriuretic peptide (NT-proBNP)(6 months)
- Changes in the Kansas City Cardiomyopathy Questionnaire(KCCQ) overall summary score from baseline(1 month, 6 months, 1 year, 2 years, 3 years)
- 6 minute walk distance(6MWD) difference from baseline(6 months, 1 year, 3 years)
- All-cause death(1 month, 6 months, 1 year, 2 years, 3 years)
- Heart/heart-lung transplantation(1 month, 6 months, 1 year, 2 years, 3 years)