TAVR with CENTERA THV for Aortic Stenosis

Not currently recruiting at 24 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Severe lung disease, Renal insufficiency, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new heart valve system, the CENTERA THV (transcatheter heart valve), to determine its safety and effectiveness for individuals with aortic stenosis. Aortic stenosis occurs when one of the heart's valves becomes too tight, hindering blood flow. The trial focuses on individuals with severe symptoms who are not at high risk for traditional heart surgery. Suitable candidates include those diagnosed with severe aortic stenosis and experiencing noticeable symptoms, such as shortness of breath during daily activities.

As an unphased trial, this study allows patients to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you must be able to tolerate antithrombotic therapy (medications that prevent blood clots) during or after the procedure.

What prior data suggests that the CENTERA THV is safe for treating aortic stenosis?

Research has shown that the CENTERA Transcatheter Heart Valve (THV) system is generally safe. In one study, the CENTERA THV demonstrated good safety results, with low death rates and improved heart function, indicating that most patients handled the device well.

Another study found that five years after the TAVR procedure, 7.2% of patients had died from heart-related issues, a rate that is low and comparable to traditional surgery. This suggests the procedure is safe over the long term.

A review of similar procedures revealed a high success rate of 98.5%, with only 6.1% of patients dying within 30 days, indicating that most patients do well shortly after the procedure.

Overall, the data shows that the CENTERA THV system is generally safe for individuals with severe narrowing of the heart's aortic valve, particularly those at intermediate risk for surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical options for aortic stenosis, such as open-heart surgery, the CENTERA Transcatheter Heart Valve (THV) offers a less invasive alternative. Researchers are excited about this treatment because it uses a catheter-based approach, allowing the valve to be implanted without opening the chest. This method could mean a shorter recovery time and less risk for patients who may not be ideal candidates for traditional surgery. Additionally, the design of the CENTERA THV aims to improve how well the valve functions and lasts over time, potentially enhancing patient outcomes.

What evidence suggests that the CENTERA THV is effective for aortic stenosis?

Research shows that the CENTERA Transcatheter Heart Valve (THV) effectively treats severe aortic stenosis. Studies have found that this treatment leads to low death rates and improves heart valve function over time. In one trial, patients experienced significant improvements in heart valve function immediately, with benefits lasting at least a year. Another study found that survival rates for patients using the CENTERA THV matched those of traditional surgery, even after two years. These findings suggest that the CENTERA THV is a reliable option for individuals with severe aortic stenosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Martin Leon, MD

Principal Investigator

Columbia University Medical Center/ NYPH

Are You a Good Fit for This Trial?

This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for surgery. Participants must have symptoms and be in NYHA functional class ≥ II. They cannot join if they have certain heart conditions, recent heart attacks or strokes, severe lung disease, kidney failure, bleeding disorders, or an allergy to Nitinol.

Inclusion Criteria

You have heart failure that affects your ability to do daily activities.

My heart team considers me at intermediate risk for open heart surgery.

The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

I have not had a serious heart infection in the last 6 months.

The medical team has assessed that you are very weak and may not be able to handle the treatment.

My aortic valve is either one-flap, two-flap, or not hardened by calcium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TAVR) using the Edwards CENTERA THV System

Follow-up

Participants are monitored for safety and valve performance after the procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CENTERA THV

Trial Overview The study tests the Edwards CENTERA Transcatheter Heart Valve System's safety and performance in those with symptomatic aortic stenosis deemed intermediate risk for surgical replacement. It involves replacing the diseased valve through a less invasive procedure than open-heart surgery.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

The LRT study is the first FDA-approved trial investigating the safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis, aiming to establish its feasibility compared to traditional surgical methods.

Patients will be monitored for 5 years post-procedure, with assessments for complications like subclinical leaflet thrombosis and regular echocardiograms to ensure the proper functioning of the valve, providing a comprehensive evaluation of TAVR's long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis: Rationale and design of the Low Risk TAVR (LRT) study. Rogers, T., Torguson, R., Bastian, R., et al.[2017]

Patients aged 50 and older undergoing surgical aortic valve replacement (SAVR) at TAVR centers had significantly lower odds of inpatient mortality (odds ratio 0.67) compared to those at non-TAVR centers, indicating better outcomes at TAVR facilities.

SAVR patients at high-volume TAVR centers experienced the lowest inpatient mortality rates (odds ratio 0.43), suggesting that the experience and resources available at these centers may enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in Inpatient Outcomes After Surgical Aortic Valve Replacement at Transcatheter Aortic Valve Replacement (TAVR) and Non-TAVR Centers. Jack, G., Arora, S., Strassle, PD., et al.[2021]

In a study of 169 patients undergoing transcatheter aortic valve replacement (TAVR) with Portico heart valves and FlexNav delivery systems, procedural success was achieved in 95.9% of cases with no procedural mortality, indicating high safety and efficacy of the intervention.

At one year post-procedure, the rates of all-cause mortality and neurological events were low at 10.7% and 7.7%, respectively, demonstrating favorable long-term outcomes and satisfactory hemodynamic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience. Yildirim, A., Genc, O., Pacaci, E., et al.[2023]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30947942/

1-Year Outcomes of the CENTERA-EU Trial Assessing a ... The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879819303875

1-Year Outcomes of the CENTERA-EU Trial Assessing a ... The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances.

3. jacc.org jacc.org/doi/10.1016/j.jcin.2019.02.024

New CENTERA Transcatheter Aortic Valve: Best of the ... Echocardiographic examination revealed significant valve improvement from baseline to 30 days with maintenance of improvement to 1 year ( ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27296202/

Two-Year Outcomes in Patients With Severe Aortic Valve ... There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% ...

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40261266/

Sex-related differences in survival and safety outcomes ... Conclusion: Men demonstrated poorer 5-year overall survival and 4-year cardiovascular survival following TAVR compared with women. Future ...

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

5-Year Outcomes After Transcatheter or Surgical Aortic ... Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24004070

Systematic Review/Meta-analysis Outcomes and Safety of ... TCv-TAVR procedures achieved a success rate of 98.5%. TCv-TAVR was associated with a 30-day ACM rate of 6.1% (95% confidence interval [CI]: 3.9%-8.2%), a 1 ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2405880

Transcatheter Aortic-Valve Replacement for Asymptomatic ... Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% ...