TAVR in Adults With Pure Severe Aortic Regurgitation

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Aortic Regurgitation

• Registration Number: NCT05737264
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-02-19
• Study First Posted: 2023-02-21
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disabling stroke	12 months	Stroke that results in a disabled state
Rehospitalization for heart failure	12 months	Rehospitalization for heart failure
all-cause mortality	12 months	Death caused by any reason

Secondary Outcome Measures

Name	Time	Method
Perioperative complications	up to 1 week	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)
New permanent pacemaker implantation(PPI)	up to 1 week	New PPI indications: 1. persistent high-degree AV block; 2. sick sinus syndrome
New complete left bundle branch block(CLBBB)	up to 1 week	Diagnostic criteria are defined as follows: 1. Rhythm must be of super-ventricular origin (EG: ventricular activation coming from atrial or AV nodal activation); 2. QRS Duration greater than 120 ms; 3. Lead V1 should have either a QS or a small r wave with large S wave; 4. Lead V6 should have a notched R wave and no Q wave.
NYHA class Ill or IV	12 months	The New York Heart Association (NYHA) class Ill or IV
Device success	intraoperative	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)
Valve-related dysfunction	12 months	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

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China