Pulmonary Hypertension study: Gradient Denervation System
Official title Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
ClinicalTrials.gov ID: NCT06495970
What this study is testing
- What it's testing
- Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- 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
- NYHA Class II or III
- Glomerular Filtration Rate (GFR) ≥ 25 ml/min
You likely can't join if
- Unwilling to provide informed consent or complete follow-up assessments
- Life expectancy of \< 2 years
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Unable to tolerate right heart catheterization
- Severe aortic, mitral or pulmonary valve regurgitation
- Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
See the full eligibility criteria
- 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
- NYHA Class II or III
- Glomerular Filtration Rate (GFR) ≥ 25 ml/min
- Unwilling to provide informed consent or complete follow-up assessments
- Life expectancy of \< 2 years
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Unable to tolerate right heart catheterization
- Severe aortic, mitral or pulmonary valve regurgitation
- Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
- Systemic infection or localized infection/rash at planned access site at time of procedure
- CRT, ICD, Pacemaker or other treatment cardiac procedure (except RHC) within the last 3 months
The study team makes the final eligibility decision.
Where it is enrolling
- Badalona, Spain
- Barcelona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Badalona, Spain; Barcelona, Spain; Valencia, Spain. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.