Transcatheter Aortic Valve Replacement for Aortic Stenosis

(ATLAS Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a heart procedure called Transcatheter Aortic Valve Replacement (TAVR) for individuals with aortic stenosis, a narrowing of the heart valve. Researchers aim to determine if performing this procedure at hospitals without nearby cardiac surgery experts is as safe and effective as performing it in hospitals with such experts. The trial includes two groups: one will undergo the procedure without surgical oversight, and the other with surgical oversight. The trial seeks participants with severe symptoms from aortic stenosis who have been approved for TAVR by a heart specialist team. As a Phase 4 trial, this research explores how the already FDA-approved and effective TAVR procedure can benefit more patients.

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 is the safety track record for these treatments?

Research shows that Transcatheter Aortic Valve Replacement (TAVR) is generally safe and well-tolerated by patients. Studies indicate that TAVR carries a lower risk of causing serious strokes and reduces the need for hospital readmission compared to traditional surgery. Patients often experience faster recovery with TAVR. The overall death rate at five years for TAVR is similar to that of surgery, approximately 14.7%. Deaths specifically from heart-related issues are slightly lower with TAVR, at 7.2% compared to 9.3% for surgery. This procedure is already approved for use, indicating its safety for many patients. The current trial, however, is testing whether TAVR can be performed safely without immediate surgical backup at hospitals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Transcatheter Aortic Valve Replacement (TAVR) techniques under investigation because they aim to improve how we handle aortic stenosis. Unlike traditional surgical options, TAVR can be performed without the need for open-heart surgery, making it a less invasive option. The study is exploring TAVR both with and without surgical oversight, which could lead to more flexible treatment settings, especially in locations without on-site surgical facilities. This could potentially expand access to life-saving procedures for patients who might not otherwise be candidates for surgery.

What evidence suggests that this trial's treatments could be effective for aortic stenosis?

Studies have shown that Transcatheter Aortic Valve Replacement (TAVR) effectively treats severe aortic stenosis, a condition where the heart's aortic valve becomes too narrow. Research indicates that TAVR and traditional valve replacement surgery have similar survival and stroke rates over five years. Notably, TAVR often results in better valve function and fewer severe complications compared to surgery. Additionally, TAVR has a lower combined rate of death, stroke, or hospital readmission after one year. This trial will compare two approaches: TAVR without surgical oversight and TAVR with surgical oversight. This evidence suggests that TAVR is a reliable option for people with aortic stenosis, regardless of the presence of a surgical team on-site. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725053355

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307447

Transcatheter Aortic-Valve Replacement in Low-Risk ... The rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR)

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014018

Three-Year Outcomes Following TAVR in Younger (<75 ... Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9115619/

Effect of Transcatheter Aortic Valve Implantation vs ... Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12375568/

Outcomes of transcatheter aortic valve replacement in ... The benefits of TAVI include a lower risk of disabling stroke, hospital readmission, and bleeding, as well as quicker improvements in symptoms ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.036179

Trends in Transcatheter Versus Surgical Aortic Valve ... TAVR was associated with a lower risk of all‐cause mortality within the first year of post‐procedural follow‐up compared with SAVR.

8. jscai.org jscai.org/article/S2772-9303(24)01365-6/fulltext

Long-Term Outcomes of Transcatheter vs Surgical Aortic ... In the analysis by transcatheter aortic valve type, as compared to SAVR, self-expanding TAVR yielded a comparable risk of death (27.60% vs 26.54 ...