New procedure targets lung pressure in heart failure: pilot study complete

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18, ≤85 years; 2. PH must be confirmed by RHC, defined as: 1. Mean pulmonary arterial pressure (mPAP) \>20mmHg, and; 2. Pulmonary capillary wedge pressure (PCWP) \>15mmHg, and； 3. Pulmonary vascular resistance (PVR) \> 2WU. 3. 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; 4. Clinically stable HF for at least 1 month, defined as: 1. No need of intravenous diuretics, inotropes or vasodilators, and 2. Systolic blood pressure (SBP) ≥ 100 and \&lt; 160 mmHg, and 3. Resting heart rate (HR) ≥ 50 bpm and \<100 bpm (\>110 bpm in presence of atrial fibrillation) on the day of the procedure. 5. NYHA class II-IVa; 6. 6MWD ≥ 100 m and ≤ 450 m; 7. NT-proBNP \>125pg/mL (or BNP \> 35pg/mL); 8. Understand and be willing to sign informed consent and be strictly willing to follow the protocol. Exclusion Criteria: 1. Any of the following: 1. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or 2. Pericardial disease; or 3. Infiltrative or inflammatory myocardial disease; or 4. Valvular heart disease with stenosis or with severe regurgitation; or 5. Active endocarditis; or 6. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or 7. Congenital heart disease; or 8. 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 9. 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 10. Anticipated to undergo ablation of atrial fibrillation within 6 months; or 11. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or 12. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD) 2. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization; 3. Anticipated to undergo any surgery within the next 6 months; 4. Cardiac index (CI) measured by RHC \< 1.5L/min/m2; 5. Severe renal insufficiency (eGFR \< 30mL/min/1.73m2 by MDRD formula); 6. Severe liver insufficiency (Child-Pugh classification B-C); 7. Platelet count \< 50 × 109/L; 8. Life expectancy \< 1 year; 9. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants; 10. Active infection requiring oral or intravenous antibiotics; 11. Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines; 12. Body mass index (BMI) \> 40 kg/m²; 13. Pregnant or lactating women, or planning to be pregnant within one year; 14. Participation in other clinical trials within 3 months prior to signing the informed consent; 15. Any other circumstances that investigators deemed inappropriate to participate in this trial.