Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)

Phase 4

Not yet recruiting

• Conditions: Severe Aortic Stenosis; Aortic Stenosis

• Registration Number: NCT06818006
• Lead Sponsor: University of Alberta

Brief Summary

The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.

Hypothesis

The investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.

Detailed Description

Primary Objectives:

The primary efficacy objective is to determine whether a Transcatheter Aortic Valve Implantation (TAVI) procedure performed by experienced operators in centers without on-site cardiac surgery is non-inferior to a TAVI procedure performed by experienced operators in centers with on-site cardiac surgery in terms of all-cause death, myocardial infarction, stroke and hospitalization for heart failure. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery (ECS) did not differ between study arms.

Research method/Procedures

ATLAS is an all-comer, prospective, randomized, multicenter, open label trial with blinded adjudicated evaluation of outcomes. The ATLAS study will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI. Participants will be recruited after Heart Team discussion and approval for TAVI. The eligibility of each participant will be confirmed by an established multidisciplinary Heart Team. Once approved for TAVI, dedicated review of the ATLAS study inclusion and exclusion criteria will occur. Study patients meeting inclusion and having no exclusion criteria will be randomized in a 2:1 fashion to TAVI performed in the experimental or standard of care arm stratified by two groups: 1) inoperable/high risk and 2) intermediate/low risk.

Randomization:

EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY After randomization, the participant will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff. CONTROL ARM: TAVI WITH ON-SITE SURGERY After randomization, the patient will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff at an established TAVI center with on-site cardiac surgery

Schedule of events:

1. Pre-eligibility screening 2. Inclusion/Exclusion criteria review 3. Randomization 4. 1-month post randomization 5. 3-months post randomization 6. TAVI procedure hospitalization 7. 1-month visit after TAVI 8. 12-month visit after TAVI 9. Final follow-up visit - 12-month post TAVI in control arm and equivalent median time post randomization in the intervention arm

Study Timeline

• Study First Submitted: 2025-01-15
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-06
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team
• Obtained informed consent

Exclusion Criteria

• Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization
• Hostile aortic root on CT for TAVI implantation defined by, but not limited to:
• High risk LVOT with a dimension significantly smaller than the annulus and/or extensive calcification
• Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and/or shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)
• High risk STJ anatomy defined by inadequate height and/or diameter and/or excessive calcification
• Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and/or unfolded aorta and/or extensive tortuosity and/or excessive iliofemoral calcification)
• GFR <15, excluding patients on dialysis
• Life expectancy less than 3 years
• Any factor precluding 1-year follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of an Emergent CardiacSurgery (ECS) event: Ventricular	From enrolment to the end of 90 day follow up	Primary Safety Outcome: Occurrence of an ECS event: Ventricular Valve Embolization, Aortic Annular Rupture, Ventricular Perforation requiring ECS or Ascending Aortic Dissection requiring ECS. Composite Endpoint of Primary Efficacy and Safety (Net clinical benefit); Multiple measurement will result in an outcome of ECS (Emergent Cardiac Surgery).
Death	From enrolment to the end of 90 day follow up	Primary Efficacy Outcome: Composite of All Cause death from randomization.
Stroke	From enrolment to the end of 90 day follow up	Primary Efficacy Outcome: Composite of All Cause Stroke, from randomization.
Heart Failure Hospitalization	From enrolment to the end of 90 day follow up	Primary Efficacy Outcome: Composite of All Cause Heart Failure Hospitalization from randomization.
Myocardial Infarction	From enrolment to the end of 90 day follow up	Primary Efficacy Outcome: Composite of All Cause myocardial infarction (MI) from randomization.

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Acute kidney injury requiring dialysis
Procedural wait time	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Procedural wait time from randomization to implantation date
Health economics analysis- Adverse Events	From enrolment to the end of 90 day follow up	Monitoring and analyzing of adverse events (AEs) weight and height will be combined to report BMI in kg/m\^2).
Health economics analysis- Long-term Outcomes	From enrolment to the end of 90 day follow up	Evaluation of the long-term effects of interventions on health and economic outcomes.
Major Bleeding	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Major (type 2-4) bleeding (VARC). Multiple measurement to determine type of bleed.
Permanent Pace Maker (PPM)	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Need for Permanent Pace Maker (PPM) during study period
Individual components of primary efficacy outcome	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Individual components of primary efficacy outcome
Hospitalization for cardiovascular cause	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Hospitalization for cardiovascular cause
Urgent percutaneous coronary revascularization	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Need for urgent percutaneous coronary revascularization
Health economics analysis- Healthcare Resource Utilization	From enrolment to the end of 90 day follow up	Evaluation of the use of healthcare services, such as hospital admissions, outpatient visits, and medication usage.
Health economics analysis- Patient-Reported Outcomes (PROs	From enrolment to the end of 90 day follow up	direct reports from patients about their health condition and treatment effects.
Emergent balloon aortic valvuloplasty	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Need for emergent balloon aortic valvuloplasty prior to TAVI implantation required because of patent deterioration or emergent
Quality of Life	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Quality of Life Baseline, 90 days post randomization, one year post randomization measured with Toronto Aortic Stenosis Quality of Life Questionnaire
Length of hospital stay	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Length of hospital stay (specific to TAVI implantation) hospitalization)
Total days of hospitalization	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Total days of hospitalization from randomization to end of study follow up
Minor Bleeding	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Minor (type 1) bleeding (VARC). Multiple measurement to determine type of bleed.
Secondary Efficacy Outcomes	From enrolment to the end of 90 day follow up	Secondary Efficacy Outcome: Major vascular complication (VARC); -Major or Minor vascular com; Multiple measure to determine the vascular complications outcomes

Trial Locations

Locations (2)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Mazankowski Heart Insitute; 🇨🇦 Edmonton, Alberta, Canada