Safety and Efficacy of Emergent TAVI in Patients With Severe AS

Not yet recruiting

• Conditions: Transcatheter Aortic Valve Implantation; Emergencies; Aortic Valve Stenosis

• Registration Number: NCT05528211
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-09-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	12 months post-TAVI	including cardiac and non-cardiac deaths.

Secondary Outcome Measures

Name	Time	Method
The incidence of other TAVI complications	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.
Valve function	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.
Cardiac function improvement	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.
Device success rate	immediate post-TAVI	Incidence of device success
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	Incidence of MACCEs (including mortality, disabling stroke, myocardial infarction, reoperation, arrhythmias and conduction blocks) during the trial.
Acute kidney injury	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) ).
Permanent pacemaker implantation	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.
Vascular complications (life-threatening or disabling)	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.