TAVR in Adults With Pure Severe Aortic Regurgitation

NCT05737264 | Unknown

• 1 other identifier: SYSKY-2022-518-01
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacement; Aortic Regurgitation

Keywords

Transcatheter Aortic Valve Replacement; Aortic Regurgitation; Observational

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Device success

  intraoperative

• Perioperative complications

  up to 1 week

• New permanent pacemaker implantation(PPI)

  up to 1 week

• New complete left bundle branch block(CLBBB)

  up to 1 week

• Valve-related dysfunction

  12 months

Study Arms (1)

TAVR group

The group that undergoes transcatheter aortic valve replacement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic regurgitation undergo transcatheter aortic valve replacement in medical centers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510123, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

ruqiong nie

CONTACT

+86 13600479016; nieruqiong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 21, 2023
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-01

Locations

CN (1)