Clinical trial NCT05737264: TAVR in Adults With Pure Severe Aortic Regurgitation
Official title: Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcatheter Aortic Valve Replacement
Aortic Regurgitation
Keywords: Transcatheter Aortic Valve Replacement
Aortic Regurgitation
Observational
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe aortic regurgitation undergo transcatheter aortic valve replacement in medical centers

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 12 months
measure: Disabling stroke
timeFrame: 12 months
measure: Rehospitalization for heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Device success
timeFrame: intraoperative
measure: Perioperative complications
timeFrame: up to 1 week
measure: New permanent pacemaker implantation(PPI)
timeFrame: up to 1 week
measure: New complete left bundle branch block(CLBBB)
timeFrame: up to 1 week
measure: Valve-related dysfunction
timeFrame: 12 months
measure: NYHA class Ill or IV
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: