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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Active Comparator | 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 Arms | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight | Procedure | Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of an Emergent CardiacSurgery (ECS) event: Ventricular | 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). | From enrolment to the end of 90 day follow up |
| Death | Primary Efficacy Outcome: Composite of All Cause death from randomization. | From enrolment to the end of 90 day follow up |
| Myocardial Infarction | Primary Efficacy Outcome: Composite of All Cause myocardial infarction (MI) from randomization. | From enrolment to the end of 90 day follow up |
| Stroke | Primary Efficacy Outcome: Composite of All Cause Stroke, from randomization. | From enrolment to the end of 90 day follow up |
| Heart Failure Hospitalization | Primary Efficacy Outcome: Composite of All Cause Heart Failure Hospitalization from randomization. | From enrolment to the end of 90 day follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of primary efficacy outcome | Secondary Efficacy Outcome: Individual components of primary efficacy outcome | From enrolment to the end of 90 day follow up |
| Hospitalization for cardiovascular cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Welsh C Welsh, MD | Contact | 780 407 2685 | Robert.Welsh@albertahealthservices.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
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strategy study of two processes with path way of care
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blinded clinical events adjudicated
| Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight | Procedure | Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight |
|
Secondary Efficacy Outcome: Hospitalization for cardiovascular cause
| From enrolment to the end of 90 day follow up |
| Permanent Pace Maker (PPM) | Secondary Efficacy Outcome: Need for Permanent Pace Maker (PPM) during study period | From enrolment to the end of 90 day follow up |
| Urgent percutaneous coronary revascularization | Secondary Efficacy Outcome: Need for urgent percutaneous coronary revascularization | From enrolment to the end of 90 day follow up |
| Acute kidney injury | Secondary Efficacy Outcome: Acute kidney injury requiring dialysis | From enrolment to the end of 90 day follow up |
| Procedural wait time | Secondary Efficacy Outcome: Procedural wait time from randomization to implantation date | From enrolment to the end of 90 day follow up |
| Length of hospital stay | Secondary Efficacy Outcome: Length of hospital stay (specific to TAVI implantation) hospitalization) | From enrolment to the end of 90 day follow up |
| Total days of hospitalization | Secondary Efficacy Outcome: Total days of hospitalization from randomization to end of study follow up | From enrolment to the end of 90 day follow up |
| Health economics analysis- Adverse Events | Monitoring and analyzing of adverse events (AEs) weight and height will be combined to report BMI in kg/m^2). | From enrolment to the end of 90 day follow up |
| Health economics analysis- Long-term Outcomes | Evaluation of the long-term effects of interventions on health and economic outcomes. | From enrolment to the end of 90 day follow up |
| Health economics analysis- Healthcare Resource Utilization | Evaluation of the use of healthcare services, such as hospital admissions, outpatient visits, and medication usage. | From enrolment to the end of 90 day follow up |
| Health economics analysis- Patient-Reported Outcomes (PROs | direct reports from patients about their health condition and treatment effects. | From enrolment to the end of 90 day follow up |
| Quality of Life | Secondary Efficacy Outcome: Quality of Life Baseline, 90 days post randomization, one year post randomization measured with Toronto Aortic Stenosis Quality of Life Questionnaire | From enrolment to the end of 90 day follow up |
| Emergent balloon aortic valvuloplasty | Secondary Efficacy Outcome: Need for emergent balloon aortic valvuloplasty prior to TAVI implantation required because of patent deterioration or emergent | From enrolment to the end of 90 day follow up |
| Major Bleeding | Secondary Efficacy Outcome: Major (type 2-4) bleeding (VARC). Multiple measurement to determine type of bleed. | From enrolment to the end of 90 day follow up |
| Minor Bleeding | Secondary Efficacy Outcome: Minor (type 1) bleeding (VARC). Multiple measurement to determine type of bleed. | From enrolment to the end of 90 day follow up |
| Secondary Efficacy Outcomes | Secondary Efficacy Outcome: Major vascular complication (VARC) -Major or Minor vascular com Multiple measure to determine the vascular complications outcomes | From enrolment to the end of 90 day follow up |
| Mazankowski Heart Insitute | Edmonton | Alberta | T6G 2B7 | Canada |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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