Actively Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency Ablation Catheter and Generator for Pulmonary Hypertension Associated With Left Heart Failure
Led by Pulnovo Medical (Wuxi) Co., Ltd. · Updated on 2024-09-20
264
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
P
Pulnovo Medical (Wuxi) Co., Ltd.
Lead Sponsor
T
The General Hospital of Northern Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of pulmonary artery denervation (PADN) in patients with heart failure who also have pulmonary hypertension linked to left heart disease. This phase III, multicenter, randomized controlled trial involves patients who have stable chronic heart failure and have been treated according to the 2023 ESC Guidelines for heart failure. The study aims to compare PADN combined with guideline-directed medical therapy (GDMT) versus GDMT alone. Participants will be randomly assigned to either receive the PADN procedure or continue their baseline heart failure medications without changes unless medically necessary. The PADN procedure involves radiofrequency ablation using a catheter to treat the pulmonary artery. Patients in the control group will maintain their current heart failure treatment as per guidelines. After a 12-month follow-up, control group participants who remain eligible may choose to receive the PADN procedure. Approximately 264 participants will be enrolled and followed for three years. During the study, participants will undergo various assessments including right heart catheterization, echocardiography, and measurement of biomarkers such as NT-proBNP, along with 6-minute walk tests and quality of life questionnaires. Researchers will monitor clinical worsening and other heart failure-related outcomes through scheduled visits at 1 month, 6 months, 1 year, 2 years, and 3 years. Safety and efficacy of the PADN system, including the radiofrequency ablation catheter and generator, will be evaluated throughout the trial.
CONDITIONS
Brief Title
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Diagnosed with chronic heart failure for at least 3 months
- Received guideline-directed medical therapy for heart failure for at least 1 month
- Clinically stable with no intravenous diuretics, inotropes, or vasodilators for at least 1 month
- Systolic blood pressure between 100 and less than 160 mmHg and resting heart rate between 50 and less than 100 bpm (less than 110 bpm for atrial fibrillation) on procedure day
- New York Heart Association (NYHA) class II-IVa
- Six-minute walk distance between 100 and less than 450 meters
- NT-proBNP greater than 125 pg/mL (or BNP greater than 35 pg/mL)
- Mean pulmonary arterial pressure greater than 20 mmHg
- Pulmonary capillary wedge pressure greater than 15 mmHg
- Willing to sign informed consent and follow the study plan
You will not qualify if you...
- Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion
- Pericardial disease
- Infiltrative or inflammatory myocardial disease
- Valvular stenosis of any valve or severe aortic/pulmonary valve regurgitation or active endocarditis
- Symptomatic carotid stenosis, transient ischemic attack, or stroke within 30 days prior to randomization
- Untreated congenital heart disease
- Coronary revascularization (CABG or PCI) within 6 months prior to randomization or planned within 6 months
- Implanted or planned pacemakers within 6 months
- Planned atrial fibrillation ablation or heart valve surgery within 6 months
- Listing for heart or heart-lung transplantation or planned ventricular assist device implantation
- Other types of pulmonary hypertension (WHO Groups 1,3,4,5)
- Use of pulmonary arterial hypertension drugs within 1 month prior to randomization
- Planned surgery within 6 months
- Cardiac index less than 1.5 L/min/m2
- Severe kidney or liver insufficiency
- Platelet count below 50 x 10^9/L
- Life expectancy less than 1 year
- Systemic inflammation or diseases requiring long-term steroids or immunosuppressants
- Active infection needing antibiotics
- Body mass index over 40 kg/m2
- Pregnant, breastfeeding, or planning pregnancy within 1 year
- Participation in other clinical trials within 3 months prior to consent
- Any other condition deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants randomized to the PADN group undergo a pulmonary artery denervation procedure involving radiofrequency ablation to the pulmonary artery to treat pulmonary hypertension associated with left heart failure.
1 procedure visit (in-person)
Duration - 12 months
Participants receive guideline-directed medical therapy for heart failure according to the 2023 ESC Guidelines, with medication regimens maintained as stable as possible through the treatment period.
Regular visits as per medical management (visit schedule varies)
Duration - Up to 3 years
Participants are followed for ongoing assessment of safety and efficacy, including clinical and echocardiographic evaluations, for up to 3 years after treatment initiation.
Visits at 1 month, 6 months, 1 year, 2 years, and 3 years
Trial Site Locations
Total: 1 location
1
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Actively Recruiting
Research Team
M
Mark Gu
Y
Yanyan Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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