Safety and Efficacy of Emergent Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Aortic Valve Stenosis (AS): a Single-center, Prospective, Observational Cohort Study.

Qilu Hospital of Shandong University0 sites10 target enrollmentSeptember 1, 2022

ConditionsAortic Valve Stenosis Transcatheter Aortic Valve Implantation Emergencies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Qilu Hospital of Shandong University
Enrollment: 10
Primary Endpoint: All-cause mortality
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI). AS patients undergoing emergent TAVI always have complicated clinical situations. Therefore, the aims of the study are to collect the incidence and outcomes of emergent TAVI in patients with severe symptomatic AS, to assess the safety and effectiveness of emergency TAVI system for severe AS, and to describe a more practical evidence of emergency TAVI system in severe AS patients.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

November 1, 2028

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Principal Investigator

Chuanbao Li

Qilu Hospital of Shandong University

Eligibility Criteria

Inclusion Criteria

•Every patient that diagnosed with severe aortic valve stenosis (evaluated by echocardiography: peak transaortic valve blood flow rate ≥4.0m/s, or mean transaortic valve pressure gradient ≥40mmHg (≥5.32kPa), or aortic Valve area \<0.8cm2, or AVA\<0.5cm2/m2);
•Every patient that 1) required cardiopulmonary resuscitation due to cardiac arrest, or requiring external chest compressions during surgery (Salvage), 2) or has ongoing, refractory (difficult, complicated, and/or unmanageable) unrelenting cardiac compromise, with or without hemodynamic instability, and not responsive to any form of therapy except cardiac surgery (STS/ACC TVT defined "Urgent Status"), 3) or required urgent procedure during same hospitalization in order to minimize chance of further clinical deterioration (examples include, but are not limited to, worsening, sudden chest pain, heart failure, acute myocardial infarction, anatomy, intra-aortic balloon pump, unstable angina with intravenous nitroglycerin or rest angina) (STS/ACC TVT defined "Urgent Status");
•Every patient that has been informed of the objectives of the study, agreed to participate, has signed the approved consent form, and was willing to accept all relevant examinations and clinical follow-up.

Exclusion Criteria

•Anatomically, the approach or aortic root is not suitable for transcatheter aortic valve implantation (TAVI).
•Anatomical morphology or vascular diseases affecting the device approach.
•Left ventricular outflow tract obstruction.
•Primary dilated cardiomyopathy.
•The echocardiogram indicates the presence of left ventricular thrombus.
•Cannot tolerate anticoagulation and antiplatelet therapy.
•Are allergic or resistant to nickel titanium alloys.
•Active infective endocarditis, or other active infections affecting the effect of TAVI.
•Severe disabling Alzheimer's disease.
•Life expectancy\< 6 months.

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: 12 months post-TAVI

including cardiac and non-cardiac deaths.

Secondary Outcomes

The incidence of other TAVI complications(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Valve function(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Cardiac function improvement(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Device success rate(immediate post-TAVI)
The incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) during the trial(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Acute kidney injury(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Permanent pacemaker implantation(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)
Vascular complications (life-threatening or disabling)(immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI)