Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996562
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2023-07-25
Brief Title:
Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart FailurePADN-CpcPH-PILOT
Sponsor:
Pulnovo Medical Wuxi Co Ltd
Organization:
Pulnovo Medical Wuxi Co Ltd
Study Overview
Official Title:
Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation PADN in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure
Participants who have received guideline-directed medical therapy GDMT according to 2022 AHAACC Guidelines for Heart Failure HF and have been clinically stable for at least 1 month will be treated with PADN and followed for 1 year
Participants who have received guideline-directed medical therapy GDMT according to 2022 AHAACC Guidelines for Heart Failure HF and have been clinically stable for at least 1 month will be treated with PADN and followed for 1 year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None