Pulmonary HypertensionThe PULSE-LHDNCT07214376
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
A study testing Pulmonary Artery Denervation (PADN) in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Pulnovo Medical, Inc. at 18 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension
- What is being tested?
- Pulmonary Artery Denervation (PADN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 21 Aug 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Subject is clinically stable, defined as:
- 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)
- PASP (RVSP) is ≥30 mmHg on the baseline TTE.
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- Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).
- Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues
- Subject has NT-proBNP ≥600 pg/mL for patients with LVEF ≤40% or ≥200 pg/mL for patients with LVEF >40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)
- Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.
- Subject or the subject's legally designated representative signs an IRB/EC approved informed consent form prior to study participation.
Who cannot join
- 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
- Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)
- Subjects with a known bleeding diathesis or who will refuse blood transfusions
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- Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation
- Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis
- Subject has congenital heart disease other than mitral valve prolapse or a PFO
- Subject had coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the prior 6 months or is anticipated to undergo CABG or PCI within 12 months after randomization.
- Subject has any pacemaker with an intracardiac sensing or pacing lead or wire implanted in the prior 3 months, or CardioMEMS HF System or other intracardiac pressure monitoring system, or cardiac contractility modulation system or baroreceptor activation therapy implanted within the prior 3 months, or any plans to implant any of these devices within 12 months after the procedure.
- Subject has undergone atrial fibrillation ablation within the prior 6 months or is anticipated to undergo atrial fibrillation ablation within 12 months after randomization.
- Subject has undergone heart valve surgery or transcatheter valve intervention within the prior 6 months or is anticipated to undergo heart valve surgery or transcatheter valve intervention (e.g., valve repair or replacement, valvuloplasty) within 12 months after randomization.
- Subject has any tricuspid or pulmonic valve implants (implanted annuloplasty rings are allowed).
- Subject has an inferior vena cava (IVC) filter implant.
- Subject has received a prior heart or heart-lung transplantation or is listed for heart or heart-lung transplantation or is anticipated to receive a ventricular assist device (VAD) implant within 6 months after randomization.
- Subjects with intracardiac thrombus on TTE.
- Subjects with pericardial effusion ≥10 mm on TTE
- Subject's PH is predominantly due to WHO Group 1, 3, 4, or 5. Note: Multifactorial features of PH may be present, but the predominant diagnosis must be WHO Group 2 CpcPH.
- Subject has been treated with any group 1 PAH-targeted drugs, including sotatercept, within the prior month or is planned to receive such therapy after randomization.
- Subject is anticipated to undergo any surgery within 6 months after randomization (other than minor surgeries requiring only local anesthesia).
- Subject has severe renal insufficiency (eGFR <30 mL/min/1.73m2 by the CKD-EPI formula, or on dialysis).
- Subject has severe liver insufficiency (Child-Pugh classification C).
- Subject has platelet count <100 × 109/L.
- Subject has systemic inflammatory or other disease requiring long-term use of oral glucocorticoids or immunosuppressants.
- Subject has active infection requiring oral or intravenous antibiotics.
- Subject has a body mass index (BMI) >45 kg/m².
- Subjects with severe respiratory disease, defined as any disorder of the respiratory system with diffusing capacity of the lungs for carbon monoxide (DLCO) <40% AND total lung capacity (TLC) <60% AND forced expiratory volume in one second (FEV1) <70% by plethysmography; OR who require ambulatory or long-term oxygen therapy
- Subject has known severe untreated sleep apnea. Note: Subjects with sleep apnea treated with CPAP/BiPAP for at least the prior 3 months are not excluded.
- Subjects with pulmonary embolism or deep vein thrombosis in the prior 6 months.
- Subject is a pregnant or breastfeeding woman, or a woman planning to become pregnant within one year. Women of child-bearing potential must have a negative pregnancy test within 1 week of randomization.
- Subject is participating in another clinical trial of an investigational drug or device that has not reached its primary endpoint.
- Subject has severe cachexia/frailty, substance abuse, or any other condition that the investigator believes may affect the subject's ability to comply with or complete all the study requirements including follow-up visits.
- Subject is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, children, impoverished persons, persons in prisons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations may also include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Amy Goodrich Harris, (757) 261-5977, goodrichharrisa@upmc.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44109
Aravinda Nanjundappa, (252) 744-4929, nanjuna@ccf.org
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Waleed Al Darzi, (800) 436-7936, waldarz1@hfhs.org
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Peter Fail, 985-876-0300, peter.fail@cardio.com
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Perwaiz Meraj, (718) 470-4420, pmeraj@northwell.edu
- Recruiting
University of Pittsburgh Medical Center
Mechanicsburg, Pennsylvania, 17050
Amy Goodrich-Harris, 717-731-0101, goodrichharrisa@upmc.edu
- Recruiting
Yale University
New Haven, Connecticut, 06520
Katherine Clark, (203) 785-6501, katherine.clark@yale.edu
- Recruiting
Mount Sinai Morningside
New York, New York, 10025
Sean Pinney, (773) 702-9396, pinneys@medicine.bsd.uchicago.edu
- Not yet recruiting
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
Oliveros Soles, (212) 305-4308, eo2578@cumc.columbia.edu
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Shmuel Chen, (212) 821-0850, shc9182@med.cornell.edu
- Recruiting
Banner - University Medical Center Tucson
Tucson, Arizona, 85711
Sorajja, (612) 863-3900, paul.sorajja@allina.com
- Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Steven Chase Stroud, 574-937-5263, steven.stroud02@oklahomaheart.com
- Recruiting
Cleveland Clinic Florida - Weston
Weston, Florida, 33331
Mauricio Cohen, (305) 243-5050, mgcohen@med.miami.edu
- Recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Clark Clark, (484) 476-1000, clarkjo@mlhs.org
China4 sites, 4 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350200
Dajun Chai, +86 15080000928, dajunchai@126.com
Wei Zhuang, +86 13635273820, Dxh_nari@sina.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiaopei Cui, +86 18560082225, cuixiaopei@sdu.edu.cn
Qiushang Ji, +86 13791123058, jiqiushang2007@sohu.com
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Hang Zhang, +86 13951922158, Dxh_nari@sina.com
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361006
Yan Wang, +86 13860488088, wy@medmail.com.cn
Xiang Chen, +86 18033997788, seanchenx@126.com
About this study
Official title: A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
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.
Read the detailed description
Roll-in Subjects:
Prior to enrollment of the first randomized subject at each site, up to two roll-in subjects per operator (maximum 2 operators per site) who meet all eligibility criteria for the randomized trial may be enrolled. Roll-in subjects will receive PADN plus GDMT. Roll-in subjects will undergo all protocol-specified assessments. The sponsor will determine when each operator has achieved acceptable experience with the PADN procedure to advance to the randomized trial, after which no further roll-in patients will be enrolled. Operators who have performed ≥3 prior PADN procedures may not need to enroll a roll-in patient prior to beginning randomization.
Randomized Subjects:
Subjects with CpcPH due to LHD who meet all eligibility criteria will be randomized in a 1:1 ratio (stratified by investigational site and by core laboratory assessed LVEF [≤40% vs >40%]) to one of the two treatment arms:
- Intervention: PADN plus GDMT
- Control: Placebo-procedure plus GDMT Subjects will undergo clinical follow-up at 1, 6, 12, 24 and 36 months. At 24 months, control subjects who have experienced a primary efficacy endpoint event and who still meet all eligibility criteria will be offered the opportunity to cross over to the PADN plus GDMT group.
- Conditions
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure
- Being tested
- Pulmonary Artery Denervation (PADN), Sham procedure control
- Keywords
- Pulmonary Artery Denervation, Pulmonary Hypertension Due to Left Heart Disease, Heart Failure, pulmonary hypertension, left heart failure
- Medical subject headings
- Hypertension, Pulmonary, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 controlDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Artery Denervation (PADN) | Experimental | PADN plus GDMT Receives: Device: Pulmonary Artery Denervation (PADN) |
| Control | Active comparator | Placebo-procedure plus GDMT Receives: Device: Sham procedure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the randomization to last enrolled patient reaches 12-month follow-up
Primary Safety Endpoint
Composite of Device-related or Procedre-related Major Adverse Events (MAEs) in the treatment group compared with a performance goal
Measured: 30-days
Secondary outcomes (13)
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
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Outpatient worsening HF events
Number of outpatients requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
All cardiovascular hospitalizations
Number of patients with cardiovascular hospitalizations
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline
Measured: 6 months, 12 months, 24 months, and 36 months
6 minute walk distance(6MWD)
6 minute walk distance(6MWD) difference from baseline
Measured: 6 months, 12 months, 24 months, and 36 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ is a self-administered, questionnaire to provide a better description of quality of life in patients with heart failure. The overall summary score range from 0 to 100, higher score means higher quality of life. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score from baseline to 30 days and 6, 12, 24, and 36 months than baseline
Measured: 6 months, 12 months, 24 months, and 36 months
durable left ventricular assist device (LVAD) implantation
durable left ventricular assist device (LVAD) implantation (time to first and all events, including recurrent events)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
heart transplantation
number of heart transplantation (time to first event)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Durable LVAD implantation
number of durable LVAD implantation (time to first event)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Cardiovascular death
number of cardiovascular death
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Atrial septostomy
number of atrial septostomy (time to first event)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
HF hospitalizations
number of HF hospitalizations (time to first and all events, including recurrent events)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Atrial shunt placement
Number of atrial shunt placement for all the subjects (time to first event)
Measured: 30days, 6 months, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start21 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At 24 months, control subjects who have experienced a primary efficacy endpoint event and who still meet all eligibility criteria will be offered the opportunity to cross over to the PADN plus GDMT group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulnovo Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg W. Stone, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214376
- Sponsor's protocol ID
- Pulnovo-CO-2025-01
- Acronym
- The PULSE-LHD
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
- ClinicalTrials.gov ID
- NCT07214376
- Acronym / sponsor ID
- The PULSE-LHD / Pulnovo-CO-2025-01
- Conditions
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure
- Keywords
- Pulmonary Artery Denervation, Pulmonary Hypertension Due to Left Heart Disease, Heart Failure, pulmonary hypertension, left heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Pulnovo Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Roll-in Subjects:
Prior to enrollment of the first randomized subject at each site, up to two roll-in subjects per operator (maximum 2 operators per site) who meet all eligibility criteria for the randomized trial may be enrolled. Roll-in subjects will receive PADN plus GDMT. Roll-in subjects will undergo all protocol-specified assessments. The sponsor will determine when each operator has achieved acceptable experience with the PADN procedure to advance to the randomized trial, after which no further roll-in patients will be enrolled. Operators who have performed ≥3 prior PADN procedures may not need to enroll a roll-in patient prior to beginning randomization.
Randomized Subjects:
Subjects with CpcPH due to LHD who meet all eligibility criteria will be randomized in a 1:1 ratio (stratified by investigational site and by core laboratory assessed LVEF [≤40% vs >40%]) to one of the two treatment arms:
- Intervention: PADN plus GDMT
- Control: Placebo-procedure plus GDMT Subjects will undergo clinical follow-up at 1, 6, 12, 24 and 36 months. At 24 months, control subjects who have experienced a primary efficacy endpoint event and who still meet all eligibility criteria will be offered the opportunity to cross over to the PADN plus GDMT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- At 24 months, control subjects who have experienced a primary efficacy endpoint event and who still meet all eligibility criteria will be offered the opportunity to cross over to the PADN plus GDMT group
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Artery Denervation (PADN) | Experimental | Device: Pulmonary Artery Denervation (PADN)PADN plus GDMT |
| Control | Active comparator | Device: Sham procedure controlPlacebo-procedure plus GDMT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Subject is clinically stable, defined as:
- PASP (RVSP) is ≥30 mmHg on the baseline TTE.
- Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).
Key exclusion criteria (34 listed)
- 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
- Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Artery Denervation (PADN)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) | Device | Pulmonary Artery Denervation (PADN) |
| Sham procedure controlIn 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) | Device | Control |
Primary outcome
Primary Efficacy Endpoint
Time frame: Immediately after the randomization to last enrolled patient reaches 12-month follow-up
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
Primary Safety Endpoint
Time frame: 30-days
Composite of Device-related or Procedre-related Major Adverse Events (MAEs) in the treatment group compared with a performance goal
13 secondary outcomes
Cumulative incidence of Major Heart Failure Events
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Outpatient worsening HF events
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
All cardiovascular hospitalizations
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: 6 months, 12 months, 24 months, and 36 months
6 minute walk distance(6MWD)
Time frame: 6 months, 12 months, 24 months, and 36 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 months, 12 months, 24 months, and 36 months
durable left ventricular assist device (LVAD) implantation
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
heart transplantation
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Durable LVAD implantation
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Cardiovascular death
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Atrial septostomy
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
HF hospitalizations
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Atrial shunt placement
Time frame: 30days, 6 months, 12 months, 24 months, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregg W. Stone principal investigator
Icahn School of Medicine at Mount Sinai
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Artery Denervation (PADN) in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Pulnovo Medical, Inc. at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MOFFETT LAURA MARY GINTANT (+1 952 303 2821, laura.moffett@pulnovomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: Immediately after the randomization to last enrolled patient reaches 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.