Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052072
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-09-18
Brief Title:
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 PreVail-PH2 Study
Sponsor:
Gradient Denervation Technologies
Organization:
Gradient Denervation Technologies
Study Overview
Official Title:
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 PreVail-PH2 Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreVail-PH2
Brief Summary:
This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Detailed Description:
Gradient has developed a novel system for pulmonary artery denervation PADN to treat patients with heart failure who also developed pulmonary hypertension PH Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality No therapeutic options are available to treat PH in this selected group of patients with heart failure The objective is to improve exercise capacity and quality of life by targeting PH in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None