Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381271
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation a Real-world Prospective Multicenter Study TRUST TAVR Registry
Status:
RECRUITING
Status Verified Date:
2024-04
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 purpose of this multicenter prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation Baseline characteristics procedural and clinical data will be collected
Detailed Description:
Pure native aortic valve regurgitation NAVR is a multifactorial valvular disease with a prevalence of moderate or severe NAVR ranging from 05 to 27 Patients with severe NAVR have a poor prognosis conservative management has a 1-year mortality rate of more than 20 Currently surgical aortic valve replacement SAVR is the recommended treatment strategy for patients with NAVR However data showed that only 20 of patients with severe NAVR and left-ventricular ejection fraction LVEF of 30-50 undergo SAVR while only 3 of those with an LVEF below 30 receive SAVR Therefore a less invasive surgical alternative therapy is needed for high surgical-risk patients from SAVR
Transcatheter aortic valve replacement TAVR is now considered the first-choice treatment for elderly patients with aortic stenosis regardless of surgical risk Recently it has also been used to treat patients with NAVR in an off-label setting The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR However the role of TAVR in patients with severe NAVR is still debatable Current studies on this topic are limited by their retrospective design and small sample sizes
Dedicated devices for aortic regurgitation such as the JenaValve have shown promising results in terms of technical success and short-term outcomes However TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation Additionally the dedicated device was designed only for tricuspid valve anatomy making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves Its worth noting that the dedicated device is not yet commercially available worldwide Therefore further investigation into TAVR using off-label devices for NAVR patients including those with bicuspid and tricuspid valves is necessary
The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting
Transcatheter aortic valve replacement TAVR is now considered the first-choice treatment for elderly patients with aortic stenosis regardless of surgical risk Recently it has also been used to treat patients with NAVR in an off-label setting The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR However the role of TAVR in patients with severe NAVR is still debatable Current studies on this topic are limited by their retrospective design and small sample sizes
Dedicated devices for aortic regurgitation such as the JenaValve have shown promising results in terms of technical success and short-term outcomes However TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation Additionally the dedicated device was designed only for tricuspid valve anatomy making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves Its worth noting that the dedicated device is not yet commercially available worldwide Therefore further investigation into TAVR using off-label devices for NAVR patients including those with bicuspid and tricuspid valves is necessary
The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting
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