Safety and Efficacy of Emergent TAVI in Patients With Severe AS

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergencies; Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Chuanbao Li, Dr; Phone Number: +86-18560083097; Email: bao2460@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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);
2. 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");
3. 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:

1. Anatomically, the approach or aortic root is not suitable for transcatheter aortic valve implantation (TAVI).
2. Anatomical morphology or vascular diseases affecting the device approach.
3. Left ventricular outflow tract obstruction.
4. Primary dilated cardiomyopathy.
5. The echocardiogram indicates the presence of left ventricular thrombus.
6. Cannot tolerate anticoagulation and antiplatelet therapy.
7. Are allergic or resistant to nickel titanium alloys.
8. Active infective endocarditis, or other active infections affecting the effect of TAVI.
9. Severe disabling Alzheimer's disease.
10. Life expectancy< 6 months.
11. Other conditions (examples include poor compliance of patients and families) considered by the investigator to be inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	including cardiac and non-cardiac deaths.	12 months post-TAVI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
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) ).	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
Permanent pacemaker implantation	Rate of patients implanted with permanent pacemaker.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
Vascular complications (life-threatening or disabling)	including dissection, occlusion, rupture and bleeding of access vessels.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
The incidence of other TAVI complications	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.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
Valve function	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.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
Cardiac function improvement	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.	immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI
Device success rate	Incidence of device success	immediate post-TAVI

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 1, 2028

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Emergencies; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 20220823LCB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No