TAVR in Adults With Pure Severe Aortic Regurgitation (SENSE-AR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Regurgitation; Transcatheter Aortic Valve Replacement

• Study Type: Observational
• Enrollment (Estimated): 76

Contacts and Locations

• Study Contact: Name: ruqiong nie; Phone Number: +86 13600479016; Email: nieruqiong@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510123
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: yanren peng; Phone Number: +86 15626278694; Email: suoxinsuo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TAVR group; The group that undergoes transcatheter aortic valve replacement

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Observational; Transcatheter Aortic Valve Replacement; Aortic Regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: SYSKY-2022-518-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No