An observational study in Aortic Valve Regurgitation, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Xijing Hospital · Observational
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
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.
164 studies on the registry are indexed under Aortic Valve Insufficiency; 54 are open to participants now.
This study's planned enrollment of 500 is above the median of 222 across 71 observational studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with pure severe native aortic valve regurgitation underwent TAVR
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Exclusion Criteria:
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
Also known as: Transcatheter aortic valve implantation
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
Time frame: 1 year
Combined early safety and clinical efficacy outcomes
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
Time frame: 30 days
Rate of technical success
* 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
Time frame: at exit from procedure room
Rate of device success
* 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)
Time frame: discharge or 30 days
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
Time frame: 2 years, 3 years, 4 years
Rate of all-cause mortality
Time frame: 5years and 10years
Valve-related long-term clinical efficacy
* 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)
Time frame: 5 years and 10 years
Plan to share: No
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Started Oct 2018 (actual). Primary completion is estimated for Oct 2034, 192 months after the start.
Of 34 observational studies under Aortic Valve Insufficiency, half reached primary completion within 86 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 132. This study's planned 192 months is above that.
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