Aortic Valve Regurgitation
Conditions
Keywords
Aortic Valve Regurgitation, TAVR, Real-Word
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 0.5% to 2.7%. 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. It's 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.
Interventions
PROCEDURETranscatheter aortic valve replacement
A total of 500 consecutive patients with NAVR undergoing TAVR will be enrolled at 3-5 centers. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years
Sponsors
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy. * 2\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
Exclusion criteria
* 1\. Patients who cannot provide informed consent * 2\. Patients who are treated with TAVR for aortic stenosis * 3\. Patients who are participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined clinical efficacy outcomes | 1 year | Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of technical success | at exit from procedure room | * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication |
| Rate of device success | discharge or 30 days | * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient\<20mmHg, and less than moderate aortic regurgitation) |
| Combined early safety and clinical efficacy outcomes | 30 days | Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events |
| Rate of all-cause mortality | 5years and 10years | — |
| Valve-related long-term clinical efficacy | 5 years and 10 years | * Freedom from bioprosthetic Valve Failure (defined as: Valve-related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration) * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis) |
| Combined clinical efficacy outcomes | 2 years, 3 years, 4 years | Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization |
Countries
China
Contacts
Primary ContactRutao Wang, M.D, Ph.D
Outcome results
None listed