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Not yet recruiting NCT05528211

Safety and Efficacy of Emergent TAVI in Patients With Severe AS

— Observational Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Emergencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Primary outcome measures

  • All-cause mortality [Time frame: 12 months post-TAVI]
Secondary outcome measures (8)
  • The incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) during the trial [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Acute kidney injury [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Permanent pacemaker implantation [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Vascular complications (life-threatening or disabling) [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • The incidence of other TAVI complications [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Valve function [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Cardiac function improvement [Time frame: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Device success rate [Time frame: immediate post-TAVI]

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.
  • Other conditions (examples include poor compliance of patients and families) considered by the investigator to be inappropriate for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05528211 · 20220823LCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗