Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03838445
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2019-02-06
Brief Title:
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension RELIEVE-PAH
Sponsor:
V-Wave Ltd
Organization:
V-Wave Ltd
Study Overview
Official Title:
RELIEVE-PAH TRIAL REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-06
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:
RELIEVE-PAH
Brief Summary:
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension including evidence of initial safety device performance and possible signals of clinical effectiveness
Detailed Description:
This is a multi-national multi-center prospective non-randomized open label trial of patients implanted with the study device A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant
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