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NCT Number: NCT05528211

Safety and Efficacy of Emergent TAVI in Patients With Severe AS

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 12 months post-TAVI

    including cardiac and non-cardiac deaths.

Secondary outcomes

  1. 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

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

  2. Acute kidney injury

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

    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) ).

  3. Permanent pacemaker implantation

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

    Rate of patients implanted with permanent pacemaker.

  4. 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

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

  5. 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

    including conversion to surgery, unexpected cardiopulmonary mechanical assistance, coronary artery occlusion, ventricular septal perforation, mitral valve injury or loss of function, pericardial tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), valve-in-valve, reoperation due to valve dysfunction, and so on.

  6. Valve function

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

    Doppler echocardiography was used to evaluate the valve performance at each follow-up point, including valve orifice area, mean aortic gradient, degree of valve regurgitation, moderate or above perivalvular leakage (PVL), and degree of aortic stenosis.

  7. Cardiac function improvement

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

    Doppler echocardiography was used to evaluate the heart function at each follow-up point, and cardiac function improvement is accessed by NYHA cardiac function classification, including NYHA class I, II, III and IV.

  8. Device success rate

    Time frame: immediate post-TAVI

    Incidence of device success

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanbao Li, Dr

CONTACT

[email protected]

+86-18560083097

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2028
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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