Heart Failure Patients With Pulmonary HypertensionPreVail-PHNCT05951166
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
A study testing Gradient Denervation System in people with Heart Failure Patients With Pulmonary Hypertension, run by Gradient Denervation Technologies at 2 sites in Georgia.
Trial summary
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Heart Failure Patients With Pulmonary Hypertension
- What is being tested?
- Gradient Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesGeorgia
- Study dates
- 5 May 2023to 1 Jul 2025
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure with EF ≥ 40% (by TTE within last 3 months)
- Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
- Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
- Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
- Cardiac index (CI) ≥ 1.7 L/min/m2
- NYHA Class II or III
Show all 9Show fewer
- Glomerular Filtration Rate (GFR) ≥ 25 ml/min
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
- Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Who cannot join
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
- Systemic infection or localized infection/rash at planned access site at time of procedure
- Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
- CRT or other Interventional cardiac procedure (except RHC) within last 3 months
- Any planned cardiac procedure or inpatient procedure within the next 30 days
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
Tbilisi Heart Clinic
Tbilisi
About this study
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension
- Being tested
- Gradient Denervation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradient Denervation SystemDevice
Pulmonary artery denervation (PADN) procedure
| Study group | Role | What they receive |
|---|---|---|
| PADN with Gradient Denervation System | Experimental | Not described Receives: Device: Gradient Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related serious adverse events
Measured: 30 days post-treatment
Secondary outcomes (1)
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Measured: 6- months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start5 May 2023
- Primary completion31 Jul 2024
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Patients With 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gradient Denervation Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951166
- Sponsor's protocol ID
- CIP-001
- Acronym
- PreVail-PH
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05951166
- Acronym / sponsor ID
- PreVail-PH / CIP-001
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Gradient Denervation TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Jul 2023 (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.
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
| Arm | Type | Receives |
|---|---|---|
| PADN with Gradient Denervation System | Experimental | Device: Gradient Denervation System |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Heart Failure with EF ≥ 40% (by TTE within last 3 months)
- Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
- Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
- Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
- Cardiac index (CI) ≥ 1.7 L/min/m2
Key exclusion criteria (6 listed)
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
- Systemic infection or localized infection/rash at planned access site at time of procedure
- Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
- CRT or other Interventional cardiac procedure (except RHC) within last 3 months
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 |
|---|---|---|
| Gradient Denervation SystemPulmonary artery denervation (PADN) procedure | Device | PADN with Gradient Denervation System |
Primary outcome
Device related serious adverse events
Time frame: 30 days post-treatment
1 secondary outcome
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Time frame: 6- months post-treatment
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 5 Mar 2025.
- Individual participant dataSharing planned: No
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Pulmonary Hypertension
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradient Denervation System in people with Heart Failure Patients With Pulmonary Hypertension, run by Gradient Denervation Technologies at 2 sites in Georgia.
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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related serious adverse events (time frame: 30 days post-treatment). 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 5 Mar 2025.