Trilogy TAVR for Aortic Regurgitation

(ARTIST Trial)

Recruiting at 1 trial location

Overseen By Duane Pinto, MD MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: JenaValve Technology, Inc.

Must not be taking: Anticoagulants, Antiplatelets, Nitinol sensitivity

Disqualifiers: Severe liver disease, Kidney disease, COPD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

1016 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Trilogy™ Transcatheter Heart Valve System for Aortic Regurgitation?

Research shows that transcatheter aortic valve replacement (TAVR), which is similar to the Trilogy™ system, has been effective in treating patients with severe aortic stenosis and those with pure aortic insufficiency, suggesting potential benefits for aortic regurgitation as well. ^{1 2 3 4 5}

Is the Trilogy TAVR system generally safe for humans?

Research shows that transcatheter aortic valve replacement (TAVR), which includes systems like Trilogy, has been studied for safety in patients with aortic stenosis, especially those at high or intermediate surgical risk. TAVR has been found to be a safe option compared to traditional surgery in these groups, with ongoing studies to confirm its safety in low-risk patients. ^{5 6 7 8 9}

How is the Trilogy TAVR treatment for aortic regurgitation different from other treatments?

The Trilogy TAVR treatment is unique because it offers a less invasive alternative to traditional open-heart surgery for aortic regurgitation, especially for patients who are at high surgical risk. Unlike surgical aortic valve replacement (SAVR), TAVR can be performed through a catheter, making it a suitable option for those who cannot undergo surgery. ^{1 2 3 10 11}

What is the purpose of this trial?

To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)

Research Team

Vinod H Thourani, MD

Principal Investigator

Piedmont Heart Institute

Torsten P Vahl, MD

Principal Investigator

Columbia University

Raj Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center

Hendrik Treede, MD

Principal Investigator

Department of Cardiovascular Surgery Johannes-Gutenberg University

Eligibility Criteria

This trial is for individuals with moderate to severe aortic regurgitation who are candidates for valve replacement. They must meet guidelines indicating they need an aortic valve replacement (AVR), have confirmed AR severity, and agree to follow-up visits. It's not specified who can't join, but typically those with conditions that prevent safe participation in the procedures would be excluded.

Inclusion Criteria

I agree to attend all follow-up visits after my procedure.

I am of legal age to consent to treatment in my area.

I have been diagnosed with severe aortic regurgitation and need valve replacement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System or Surgical Aortic Valve Replacement (SAVR)

30 days

In-hospital stay for procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for stroke, mortality, and rehospitalization

12 months

Regular follow-up visits

Long-term follow-up

Participants are monitored for Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

10 years

Treatment Details

Interventions

• Surgical Aortic Valve Replacement (SAVR)
• Trilogy™ Transcatheter Heart Valve System

Trial Overview The ARTIST trial is testing whether the Trilogy Transcatheter Heart Valve System is as effective as traditional surgical aortic valve replacement (SAVR) in treating significant native aortic regurgitation without being worse than SAVR.

Participant Groups

Group I: Transcatheter Aortic Valve Replacement (TAVR) Experimental Treatment 1 Intervention

Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System

Group II: SAVR Experimental Treatment 1 Intervention

SAVR using commercially available surgical prosthetic valve

Who Is Running the Clinical Trial?

JenaValve Technology, Inc.

Lead Sponsor

Trials

8

Recruited

2,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement vs Surgical Replacement in Patients With Pure Aortic Insufficiency. [2021]

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

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

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

Learning curve for transcatheter aortic valve replacement for native aortic regurgitation: Safety and technical performance study. [2021]

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

Outcomes of intermediate-risk patients treated with transcatheter and surgical aortic valve replacement in the Veterans Affairs Healthcare System: A single center 20-year experience. [2019]

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

Trends in volume and risk profiles of patients undergoing isolated surgical and transcatheter aortic valve replacement. [2020]

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

Meta-Analysis of Transcatheter Aortic Valve Replacement in Low-Risk Patients. [2020]

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

An updated meta-analysis of TAVR in patients at intermediate risk for SAVR. [2020]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Should TAVR Replace Surgery for Aortic Stenosis in Low- to Intermediate-Risk Patients? [2018]

10. Australia pubmed.ncbi.nlm.nih.gov

Expanding role for transcatheter aortic valve replacement: successful transfemoral implantation of a Medtronic CoreValve for severe aortic regurgitation. [2012]

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

Expanding Indications of Transcatheter Heart Valve Interventions. [2016]