TAVR with CENTERA THV for Aortic Stenosis

Recruiting at 22 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

101 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CENTERA THV for aortic stenosis?

Research shows that transcatheter aortic valve replacement (TAVR), which includes treatments like CENTERA THV, improves survival rates in patients with severe aortic stenosis, especially those at high risk for surgery. TAVR has been found to be more effective than traditional surgery in certain cases, leading to better outcomes for patients. ^{1 2 3 4 5}

Is TAVR with CENTERA THV generally safe for humans?

There is no specific safety data available for the CENTERA THV in the provided research articles. ^{6 7 8 9 10}

How is the CENTERA THV treatment for aortic stenosis different from other treatments?

The CENTERA THV is unique because it is a self-expanding valve made from bovine pericardial tissue, which allows for repositioning during the procedure. It uses a motorized delivery system that is compatible with a smaller catheter size (14-F), potentially making the procedure less invasive compared to other transcatheter heart valves. ^{5 6 11 12 13}

What is the purpose of this trial?

This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

Research Team

Martin Leon, MD

Principal Investigator

Columbia University Medical Center/ NYPH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Differences in Inpatient Outcomes After Surgical Aortic Valve Replacement at Transcatheter Aortic Valve Replacement (TAVR) and Non-TAVR Centers. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany. [2022]

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

3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Balloon-Expandable and Self-Expanding Transcatheter Heart Valves: Friend or Foe? [2016]

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

Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients. [2020]

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

The Allegra transcatheter heart valve: Short term results from a multicenter registry. [2022]

8. United States 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. [2017]

9. France pubmed.ncbi.nlm.nih.gov

A systematic review on the safety of second-generation transcatheter aortic valves. [2018]

10. Switzerland 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. [2023]

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

Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. [2019]

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

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repeat transcatheter aortic valve replacement for the treatment of transcatheter prosthesis dysfunction. [2021]