Trilogy TAVR for Aortic Regurgitation

(ARTIST Trial)

Recruiting at 16 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve system called the Trilogy Transcatheter Heart Valve (THV) System. Researchers aim to determine if it performs as well as traditional surgery for individuals with serious aortic regurgitation, a condition where the heart's aortic valve doesn't close properly. Participants will either receive the new Trilogy valve through a less invasive procedure or undergo traditional heart valve surgery, known as Surgical Aortic Valve Replacement (SAVR). Individuals advised to replace their aortic valve due to moderate to severe leakage might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to less invasive treatment options for future patients.

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 prior data suggests that the Trilogy Transcatheter Heart Valve System is safe for treating aortic regurgitation?

Research has shown that the Trilogy Transcatheter Heart Valve (THV) System is generally well-accepted by patients. In a study of 500 patients, the device succeeded in over 95% of cases, indicating strong performance for most individuals. This study also found that the Trilogy system had better success rates compared to other valves for treating aortic regurgitation (AR), which typically achieve success rates between 80% and 85%.

Regarding safety, tests on the JenaValve THV system, part of the Trilogy family, involved patients at high risk for surgical complications. These tests demonstrated that the valve is safe and effective for these patients.

While the sources do not specifically mention any negative side effects, the high success rate and positive results in high-risk patients suggest that the Trilogy THV System is a promising option for treating aortic regurgitation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for aortic regurgitation involve Surgical Aortic Valve Replacement (SAVR), which requires open-heart surgery to replace the faulty valve. The Trilogy™ Transcatheter Heart Valve System is unique because it allows for Transcatheter Aortic Valve Replacement (TAVR), a less invasive procedure. Unlike SAVR, TAVR can be done through a catheter, minimizing recovery time and reducing surgical risks. Researchers are excited because this approach could make valve replacement accessible to patients who are not suitable candidates for traditional surgery.

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

This trial will compare the Trilogy Transcatheter Heart Valve (THV) System with Surgical Aortic Valve Replacement (SAVR) for treating aortic regurgitation (AR). Studies have shown that the Trilogy THV System achieves over 95% success in treating AR in a group of 500 patients, surpassing the usual success rates of 80-85% with other available heart valves. Research also indicates that the Trilogy THV System can significantly reduce blood backflow after implantation. These early findings suggest that the Trilogy THV System offers a promising option for patients with severe AR, providing good long-term results and stability. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39290676/

Quantitative Aortography Analysis of JenaValve's Trilogy ... Quantitative aortography confirms the low rates of AR and the large reduction in RF following the implantation of Jenavalve's Trilogy THV, ...

2. jenavalve.com jenavalve.com/align-ar-first-500-patients-data/

ALIGN-AR First 500 Patients Data “We now have a device success rate of over 95% across 500 patients compared to the success rates of 80 to 85% with available TAVR valves when used in AR ...

3. jacc.org jacc.org/doi/10.1016/j.jaccas.2024.102670

Long-Term Outcomes and Durability of a Novel Dedicated ... Long-term (5-year) outcomes demonstrate sustained valve hemodynamics and clinical stability, highlighting J-Valve as a promising minimally invasive alternative ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2474870624001015

Quantitative Aortography Analysis of JenaValve's Trilogy ... The JenaValve's Trilogy transcatheter heart valve (THV) system is the only CE-marked THV system for severe aortic regurgitation (AR), but its efficacy has not ...

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/JVT24001

JenaValve Trilogy Transcatheter Heart Valve System Versus ... The purpose of this study is to determine whether an experimental device called the Trilogy Transcatheter Heart Valve (THV) System is as effective.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06608823

ARTIST: Aortic Regurgitation Trial Investigating Surgery ... Higher scores mean better outcome. 30 days. Atrial fibrillation, comparing the onset atrial fibrillation in TAVR with SAVR, 30 days. Cardiovascular ...