Transcatheter Aortic Valve Replacement for Aortic Stenosis

(ATLAS Trial)

Recruiting at 1 trial location

Overseen By Dr. Robert Welsh C Welsh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alberta

Disqualifiers: Ambiguous aortic annular sizing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Transcatheter Aortic Valve Replacement (TAVR) for Aortic Stenosis?

Research shows that TAVR is an effective alternative to surgical aortic valve replacement for patients with severe aortic stenosis, especially those at high surgical risk. It has been associated with improved survival and health status compared to medical therapy alone. ^{1 2 3 4 5}

Is Transcatheter Aortic Valve Replacement (TAVR) generally safe for humans?

Transcatheter Aortic Valve Replacement (TAVR) is considered a valid option for patients with high or intermediate surgical risk, and it has been approved by the FDA for severe aortic stenosis in patients who cannot undergo surgery. However, safety data for low-risk patients is still limited, and more research is needed to fully understand the safety outcomes in this group. ^{6 7 8 9 10}

How does Transcatheter Aortic Valve Replacement (TAVR) differ from other treatments for aortic stenosis?

Transcatheter Aortic Valve Replacement (TAVR) is unique because it is a less invasive procedure compared to traditional surgical aortic valve replacement (SAVR), making it a suitable option for patients who are at intermediate, high, or extreme risk for surgery. TAVR can be performed with or without surgical oversight, offering flexibility in its administration. ^{1 2 4 11 12}

Eligibility Criteria

This trial is for individuals with aortic stenosis, which is a narrowing of the heart's aortic valve. Participants should be eligible for Transcatheter Aortic Valve Replacement (TAVR). The study excludes those who don't meet specific health criteria set by the researchers.

Inclusion Criteria

Obtained informed consent

My severe aortic stenosis has been approved for a specific heart valve procedure.

Exclusion Criteria

My heart valve measurement increases the risk of a part moving to another place.

My heart and vessels may not be suitable for a specific valve surgery due to various risks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Pre-procedure

Participants are randomized and prepared for the TAVI procedure, including review of inclusion/exclusion criteria and Heart Team approval

1-2 weeks

TAVI Procedure

Participants undergo the TAVI procedure either with or without on-site cardiac surgery

Hospitalization period

Post-procedure Follow-up

Participants are monitored for safety and effectiveness, with visits at 1 month, 3 months, and 12 months post-TAVI

12 months

3 visits (in-person)

Final Follow-up

Final follow-up visit to assess long-term outcomes and safety

12 months post-TAVI

Treatment Details

Interventions

• Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
• Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight

Trial Overview The ATLAS Study tests if TAVR without on-site cardiac surgery oversight has similar outcomes to TAVR with such oversight. It's a randomized trial comparing these two approaches in experienced interventional cardiac centers.

Participant Groups

Group I: Experimental Arm Active Control 1 Intervention

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.

Group II: Control Arms Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

A systematic review of 20 studies involving 2,775 high surgical-risk patients showed that transcatheter aortic valve replacement (TAVR) significantly improves functional capacity, with an increase of over 40 meters in the 6-minute walk test after the procedure.

Patients also experienced a meaningful enhancement in health-related quality of life (HRQoL), with notable improvements in physical activity scores, indicating that TAVR is a beneficial treatment option for those with severe aortic stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional capacity and health-related quality of life outcomes post transcatheter aortic valve replacement: a systematic review and meta-analysis. Straiton, N., Jin, K., Bhindi, R., et al.[2019]

In a study of 72,356 hospitalizations for aortic valve replacement in patients under 60, TAVR showed lower procedural complications compared to SAVR, while maintaining a similar mortality rate (2.9% vs. 3.0%).

TAVR patients experienced a shorter hospital stay (4 days vs. 6 days) without a significant difference in 30-day readmission rates, indicating favorable short-term outcomes for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients Gad, MM., Elgendy, IY., Saad, AM., et al.[2022]

Transcatheter aortic valve replacement (TAVR) is a safe and effective treatment for patients with symptomatic aortic stenosis who are at very high risk for traditional surgery, with a 30-day hospital mortality rate of 8%, similar to outcomes from the PARTNER trials.

In a study of 160 patients evaluated for TAVR, 31% were deemed appropriate candidates, and the implementation of lessons from previous trials allowed for a short learning curve and successful outcomes in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement program in the post-food and drug administration approval era: early outcomes at an academic medical center. Melby, SJ., Bess, KM., Isbell, KD., et al.[2015]

About 9.5% of patients receiving transcatheter aortic valve replacement (TAVR) in the U.S. were treated for off-label indications, which include conditions like bicuspid valve and severe mitral regurgitation.

Patients receiving off-label TAVR had higher in-hospital and 30-day mortality rates compared to those receiving on-label TAVR, but after one year, mortality rates were similar, indicating a need for further research on the safety and efficacy of off-label TAVR use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement: Insights From the NCDR STS/ACC TVT Registry. Hira, RS., Vemulapalli, S., Li, Z., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Evolving trends in aortic valve replacement: A statewide experience. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Functional capacity and health-related quality of life outcomes post transcatheter aortic valve replacement: a systematic review and meta-analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement program in the post-food and drug administration approval era: early outcomes at an academic medical center. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement: Insights From the NCDR STS/ACC TVT Registry. [2020]

10. China pubmed.ncbi.nlm.nih.gov

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation of Transcatheter Aortic Valve Replacement in France. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Transfemoral aortic valve replacement with the SAPIEN XT valve: step-by-step. [2012]