Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation

Aortic Valve Regurgitation Clinical Trial

Official title:

Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381271
• Other study ID #: TRUST TAVR Registry
• Status: Recruiting
• Start date: October 30, 2018
• Est. completion date: October 2034

Study information

• Verified date: April 2024
• Source: Xijing Hospital
• Contact: Rutao Wang, M.D, Ph.D
• Phone: +86-15091095796
• Email: rutaowang[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2034
• Est. primary completion date: October 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation

Intervention

Procedure:
• Transcatheter 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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined clinical efficacy outcomes	Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization	1 year
Secondary	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	30 days
Secondary	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	at exit from procedure room
Secondary	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)	discharge or 30 days
Secondary	Combined clinical efficacy outcomes	Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization	2 years, 3 years, 4 years
Secondary	Rate of all-cause mortality		5years and 10years
Secondary	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)	5 years and 10 years