Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure: A Pilot Study

Pulnovo Medical (Wuxi) Co., Ltd.2 sites in 1 country30 target enrollmentJune 28, 2024

ConditionsPulmonary Hypertension Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Hypertension
Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
Enrollment: 30
Locations: 2
Primary Endpoint: 6-minute walk distance (6MWD) difference
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure.

Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.

Registry

clinicaltrials.gov

Start Date

June 28, 2024

End Date

January 15, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pulnovo Medical (Wuxi) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18, ≤85 years;
•PH must be confirmed by RHC, defined as:
•Mean pulmonary arterial pressure (mPAP) \>20mmHg, and;
•Pulmonary capillary wedge pressure (PCWP) \>15mmHg, and；
•Pulmonary vascular resistance (PVR) \> 2WU.
•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;
•Clinically stable HF for at least 1 month, defined as:
•No need of intravenous diuretics, inotropes or vasodilators, and
•Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg, and
•Resting heart rate (HR) ≥ 50 bpm and \<100 bpm (\>110 bpm in presence of atrial fibrillation) on the day of the procedure.

Exclusion Criteria

•Any of the following:
•Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
•Pericardial disease; or
•Infiltrative or inflammatory myocardial disease; or
•Valvular heart disease with stenosis or with severe regurgitation; or
•Active endocarditis; or
•Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
•Congenital heart disease; or
•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
•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