Comparison of Eligible TAVI-valves - Cohort B

Transcatheter Aortic Valve Implantation Clinical Trial

— Compare-TAVI  

Official title:

Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443023
• Other study ID #: Compare-TAVI
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: December 2023
• Source: Aarhus University Hospital Skejby
• Contact: christian j terkelsen, Professor
• Phone: 004587452017
• Email: chriterk[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

Description:

The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances. Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve. Hypotheses: 1. There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared. 2. There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI. Design: Randomized controlled trial with clinical national registry follow-up. Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria. Randomization: Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves. Consecutive cohorts are established. In the current study we plan to initiate the following cohorts: Cohort B: Patients randomized to the Sapien or the Myval TAVI valve. Operator requirements: Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1062
• Est. completion date: December 31, 2032
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient more than 18 years of age.

2. Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference.

3. The center experience for each of the valves considered should be more than 15 cases a year, and at least 15 valves implanted before a valve can be used in the trial.

4. The center volume should be more than 75 cases a year.

5. The patient has given signed informed consent.

6. TAVI performed via the femoral artery.

Exclusion Criteria:

1. Not able to give written inform consent

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Implantation

Intervention

Device:
• chosen TAVI valve
chosen TAVI valve

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aalborg University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with MACE (Major Adverse Cardiovascular Events)	Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria	1 year
Secondary	Percentage of patients with MACE	Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria	30 day, 3-year, 5-year and 10-year
Secondary	Percentage death	Mortality	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with stroke	According to Valve Academic Research Consortium (VARC)-3 criteria	During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with moderate or severe paravalvular leakage	Moderate or severe paravalvular leakage according to VARC-3 criteria	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with moderate/major aortic stenosis	According to VARC-3 criteria	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with new pacemaker	New Pacemaker after TAVI-procedure	During admission, 30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with major bleeding	Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg>=1.86 mmol/l or >=2 units of blood transfusion	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Distance in meters during 6-minute walk test	6-minute walk test	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with other TAVI-related complications	conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria	During TAVI-procedure
Secondary	Percentage of patients with endocarditis	Endocarditis	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Proportion with successful implantation of the chosen valve.	This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death.	During procedure
Secondary	Percentage of patients with major vascular access site and access-related complications	According to VARC-3 criteria	During admission and 30-day
Secondary	Percentage of patients with valve thrombosis or severe stenosis	Valve thrombosis or severe stenosis confirmed by Echo or HCT	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with readmission with congestive heart failure	Readmission with congestive heart failure	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Percentage of patients with increase in creatinin level of 100% or more, or dialysis	Increase in renal creatinine level more than to >=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis	during admission and within 30 days
Secondary	Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups	Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)	30-day
Secondary	Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups	Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)	30-day
Secondary	Percentage of patients with prosthesis-patient mismatch	Prosthesis-patient mismatch (EOA/body surface area). Severe PPM=0.65 cm2/m2. Moderate PPM=0.85 cm2/m2 according to VARC-3 criteria	30-day, 1-year, 3-year, 5-year, 10-year
Secondary	Mean effective orifice area measured by MRI	Effective orifice area measured by MRI in patients participating in MRI-substudy	30-day
Secondary	Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT	Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy	30-day and 1-year
Secondary	Mean volume of aortic regurgitation measured by MRI	Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy	30-day
Secondary	Other tavi-related complications	Anulus rupture or aortic rupture	30-day
Secondary	AMI	Acute Myocardial Infarction	30-day, 1-year, 3-year, 5-year and 10-year
Secondary	PCI og CABG	Percutaneous Coronary Intervention or coronary artery bypass grafting	30-day, 1-year, 3-year, 5-year and 10-year
Secondary	Reopeation	Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria	30-day, 1-year, 3-year, 5-year and 10-year
Secondary	Afib	Newly diagnosed atrial fibrillation according to VARC-3 criteria	30-day, 1-year, 3-year, 5-year and 10-year.