Safety and Efficacy of Emergent TAVI in Patients With Severe AS

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

consecutive patients with severe aortic valve stenosis undergoing emergency transcatheter aortic valve implantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

All-cause mortality

including cardiac and non-cardiac deaths.

Time frame
12 months post-TAVI

Secondary outcomes

1

The incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) during the trial

Incidence of MACCEs (including mortality, disabling stroke, myocardial infarction, reoperation, arrhythmias and conduction blocks) during the trial.

Time frame
immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
2

Acute kidney injury

Incidence of acute kidney injury (kidney function was accessed by AKIN kidney function classification, including AKIN class II, AKIN class III and renal replacement therapy (RRT: hemodialysis, peritoneal dialysis, hemofiltration) ).

Time frame
immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
3

Permanent pacemaker implantation

Rate of patients implanted with permanent pacemaker.

Time frame
immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
4

Vascular complications (life-threatening or disabling)

including dissection, occlusion, rupture and bleeding of access vessels.

Time frame
immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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