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A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease

ConditionsPulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulnovo Medical, Inc.

About this trial

The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)

Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥18 and ≤85 years of age

Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment

No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure

SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)

Disqualifiers

Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.

Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis

Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve

Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Artery Denervation (PADN)

    Device

    In patients randomized to Intervention, a Contrast pulmonary artery (PA) angiography will be performed to identify the pulmonary artery bifurcation and measure the PA diameter. Once the anatomy is deemed suitable, a radiofrequency ablation catheter will be introduced into the ostium of the left PA and the distal bifurcation of the main PA. The catheter will be maneuvered within the PA to deliver energy circumferentially, ensuring tight electrode contact with the endovascular surface. Approximately three ablations will be performed at a target temperature of 50 °C (range 45-55 °C) for 120 seconds each at both the left PA ostium and the distal main PA bifurcation. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)

  • Sham procedure control

    Device

    In patients randomized to a placebo-procedure, a script will be followed for approximately 20 minutes to simulate the PADN procedure. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Pulmonary Artery Denervation (PADN)Experimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Efficacy Endpoint

Composite of Major Heart Failure Events (MHFE). Based on a time-to-first event analysis at 24-month follow-up evaluated when the last enrolled patient reaches 12-month follow-up: 1. Cardiovascular death; 2. Heart transplantation or durable left ventricular assist device (LVAD) implantation; 3.HF hospitalizations; 4. Outpatient worsening HF events

Time frame
Immediately after the randomization to last enrolled patient reaches 12-month follow-up
2

Primary Safety Endpoint

Composite of Device-related or Procedre-related Major Adverse Events (MAEs) in the treatment group compared with a performance goal

Time frame
30-days

Secondary outcomes

1

Cumulative incidence of Major Heart Failure Events

All the following events as following: 1. Cardiovascular death; 2.Heart transplantation or durable left ventricular assist device (LVAD) implantation; 3.HF hospitalizations ; 4.Outpatient worsening HF events

Time frame
30days, 6 months, 12 months, 24 months, and 36 months
2

Outpatient worsening HF events

Number of outpatients requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure

Time frame
30days, 6 months, 12 months, 24 months, and 36 months
3

All cardiovascular hospitalizations

Number of patients with cardiovascular hospitalizations

Time frame
30days, 6 months, 12 months, 24 months, and 36 months
4

N-terminal pro-B-type natriuretic peptide (NT-proBNP)

Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline

Time frame
6 months, 12 months, 24 months, and 36 months

Other outcomes

1

Device-related or Procedure-related Major Adverse Events

Composite of Device-related or Procedure-related Major Adverse Events (MAE) in the treatment group compared with a Performance Goal, defined as the composite of: 1. All-cause mortality; 2.Deep venous thrombosis or pulmonary embolism 3.Perforation or dissection of the pulmonary artery requiring surgical treatment ; 4.Pulmonary artery aneurysm; 5. Pulmonary artery stenosis; 6.Hemoptysis requiring surgical treatment; 7.Left recurrent laryngeal nerve injury; 8. Major vascular complications; 9.BARC type 3 or 5 bleeding; 10.Infection requiring intravenous antibiotics; 11.Endotracheal intubation; 12.Permanent implantation of a pacemaker or defibrillator

Time frame
30 days, 6 months, 12 months, 24 months, and 36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pulnovo Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
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