Safety and Efficacy of Emergent TAVI in Patients With Severe AS

Aortic Valve Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05528211
• Other study ID #: 20220823LCB
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: November 1, 2028

Study information

• Verified date: September 2022
• Source: Qilu Hospital of Shandong University
• Contact: Chuanbao Li, Dr
• Phone: +86-18560083097
• Email: bao2460[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 1, 2028
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Emergencies
• Transcatheter Aortic Valve Implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	including cardiac and non-cardiac deaths.	12 months post-TAVI
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Device success rate	Incidence of device success	immediate post-TAVI