Safety and Efficacy of Emergent TAVI in Patients With Severe AS

NCT05528211 | Not Yet Recruiting

• 1 other identifier: 20220823LCB
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Emergencies

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  including cardiac and non-cardiac deaths.

  12 months post-TAVI

Secondary Outcomes (8)

• 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

• The incidence of other TAVI complications

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Emergencies

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chuanbao Li, Dr

CONTACT

+86-18560083097; bao2460@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 6, 2022

Record last verified: 2022-09