TAVR in Adults With Pure Severe Aortic Regurgitation

Transcatheter Aortic Valve Replacement Clinical Trial

— SENSE-AR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737264
• Other study ID #: SYSKY-2022-518-01
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: ruqiong nie
• Phone: +86 13600479016
• Email: nieruqiong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency
• Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	Death caused by any reason	12 months
Primary	Disabling stroke	Stroke that results in a disabled state	12 months
Primary	Rehospitalization for heart failure	Rehospitalization for heart failure	12 months
Secondary	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
Secondary	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
Secondary	New permanent pacemaker implantation(PPI)	New PPI indications: persistent high-degree AV block; sick sinus syndrome	up to 1 week
Secondary	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
Secondary	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
Secondary	NYHA class Ill or IV	The New York Heart Association (NYHA) class Ill or IV	12 months