Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824923
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-01-10
Brief Title:
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Sponsor:
Pulnovo Medical Wuxi Co Ltd
Organization:
Pulnovo Medical Wuxi Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency RF Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
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:
PADN-HF-PH
Brief Summary:
Its a phase III prospective multicenter randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation PADN for heart failure HF patients diagnosed with pulmonary hypertension associate with left heart disease PH-LHD by right heart catheterization
Detailed Description:
Chronic heart failure CHF patients who have received guideline-directed medical therapy GDMT based on the 2023 ESC Guidelines for HF and have reached clinical stable and diagnosed with PH-LHD by right heart catheterization will be randomized to the PADN group or control group in a 11 ratio to receive PADN combined with HF GDMT or HF GDMT respectively After the 12-month follow-up visit is completed participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN
Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years The safety and efficacy of the PADN system including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group
Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years The safety and efficacy of the PADN system including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group
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