SENSE-AR: TAVR in Adults With Pure Severe Aortic Regurgitation

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05737264

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Aortic Valve Replacement Aortic Regurgitation

Study Design

Study Type:

Observational

Anticipated Enrollment :

76 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
TAVR group The group that undergoes transcatheter aortic valve replacement

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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: persistent high-degree AV block sick sinus syndrome
New complete left bundle branch block(CLBBB) [up to 1 week]
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.
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
NYHA class Ill or IV [12 months]
The New York Heart Association (NYHA) class Ill or IV

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510123

Sponsors and Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05737264

Other Study ID Numbers:

SYSKY-2022-518-01

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Transcatheter Aortic Valve Replacement

Aortic Regurgitation

Observational

Additional relevant MeSH terms:

Aortic Valve Insufficiency

Study Results

No Results Posted as of Feb 21, 2023