TAVR in Adults With Pure Severe Aortic Regurgitation

Study Overview
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Brief Summary
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The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.

Official Title
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Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)

Conditions
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Transcatheter Aortic Valve Replacement, Aortic Regurgitation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years; Patients with severe aortic regurgitation (> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width > 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2 TAVR has been performed; Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up. Exclusion Criteria: History of aortic valve replacement; Combined with moderate-severe mitral regurgitation and moderate aortic stenosis; Acute endocarditis or other acute cardiac inflammation; Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent); Other conditions judged by the investigator as not suitable for the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR group<br>The group that undergoes transcatheter aortic valve replacement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | Death caused by any reason | 12 months | 
| Disabling stroke | Stroke that results in a disabled state | 12 months | 
| Rehospitalization for heart failure | Rehospitalization for heart failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation) | intraoperative | 
| Perioperative complications | Perioperative complications conclude Life-threatening bleeding, Acute kidney injury-Stage 2 or 3 (including renal replacement therapy), Coronary artery obstruction requiring intervention, Major vascular complications, and Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) | up to 1 week | 
| New permanent pacemaker implantation(PPI) | New PPI indications: persistent high-degree AV block sick sinus syndrome | up to 1 week | 
| New complete left bundle branch block(CLBBB) | Diagnostic criteria are defined as follows: Rhythm must be of super-ventricular origin (EG: ventricular activation coming from atrial or AV nodal activation) QRS Duration greater than 120 ms Lead V1 should have either a QS or a small r wave with large S wave Lead V6 should have a notched R wave and no Q wave. | up to 1 week | 
| Valve-related dysfunction | Mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm and DVI <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation, and/or Prosthetic valve endocarditis, and/or Prosthetic valve thrombosis | 12 months | 
| NYHA class Ill or IV | The New York Heart Association (NYHA) class Ill or IV | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, Aortic Regurgitation, Observational