Portico Valve for Aortic Stenosis

(PORTICO-IDE Trial)

Not currently recruiting at 71 trial locations

Overseen By Kimberly S Behning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Aspirin, Heparin, Ticlid, Plavix

Disqualifiers: Myocardial infarction, Prosthetic heart valve, Renal insufficiency, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 37

Duration: 30 days

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 Portico Valve for individuals with severe aortic stenosis, a condition where the heart's aortic valve doesn't open properly. Researchers aim to determine if this new valve is safe and effective compared to other available valves. The trial includes different groups, one specifically for those whose previous valve surgery didn't succeed as planned. This trial might suit individuals experiencing symptoms like fatigue or chest pain due to aortic stenosis, especially if surgery poses significant risks. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment option.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), you may be excluded from the trial.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Portico Transcatheter Aortic Valve System is safe for treating aortic stenosis?

Research has shown that the Portico Transcatheter Aortic Valve System is safe. One study found the Portico valve to be as safe and effective as other options, with patients experiencing low rates of complications and death. Another review noted a strong safety record for the system, with very few serious side effects reported in the first 30 days. Additionally, the FlexNav delivery system used with the Portico valve proved safe and provided lasting benefits for over a year. Overall, evidence suggests that patients tolerate the Portico valve well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Portico Valve System is unique because it offers a re-sheathable design that allows for precise placement during the procedure, which is a significant improvement over many existing transcatheter aortic valves. This feature can potentially reduce complications and improve outcomes for patients with aortic stenosis. Additionally, the FlexNav delivery system used with the Portico Valve offers enhanced flexibility and control, making the procedure less invasive and potentially safer for patients. Researchers are excited about these innovations because they could lead to better patient experiences and outcomes compared to the current standard treatments.

What evidence suggests that the Portico Valve is effective for treating aortic stenosis?

Research has shown that the Portico Valve System effectively treats severe aortic stenosis, a condition where the heart's aortic valve narrows excessively. In this trial, participants may receive the Portico Valve System, which studies indicate is as safe and effective as other valves. For instance, one study found that patients experienced positive results a year after receiving the Portico valve, with few complications. Another study confirmed that the Portico Valve System meets safety and effectiveness standards compared to other treatments. Overall, the Portico Valve System appears promising for those needing a new aortic valve. ^{1 6 7 8 9}

Who Is on the Research Team?

Raj Makkar

Principal Investigator

Cedars-Sinai Medical Center

Gregory Fontana, M.D.

Principal Investigator

Los Robles Regional Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 21 with severe symptomatic aortic valve stenosis who are at high or extreme risk for surgery, as determined by specific health criteria and consultations. Participants must be able to attend follow-up visits, have certain heart function classifications (NYHA II-IV), and an aortic annulus size of 19-27mm. Exclusions include recent heart attacks, certain valve abnormalities, blood disorders, uncontrolled coronary artery disease, kidney failure on dialysis, active infections within the past six months, life expectancy less than one year due to other diseases.

Inclusion Criteria

Doctors agree surgery is too risky for me due to high chances of death or serious harm.

I have severe aortic valve stenosis confirmed by an echo test within the last 60 days.

I have symptoms of aortic stenosis and my activity is somewhat to severely limited.

Exclusion Criteria

I have a history of heart bypass surgery that may affect treatment access.

I have a heart valve implant or severe heart valve issues.

I have severe heart failure requiring medication or mechanical support.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Portico Transcatheter Heart Valve or any FDA-approved TAVR System

30 days

Baseline, peri- and post-procedure, at discharge or 7 days post-procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

30 days, 6 months, 12 months, and annually through 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Portico Re-sheathable Transcatheter Aortic Valve System

Trial Overview The PORTICO trial tests the safety and effectiveness of the St Jude Medical Portico Transcatheter Heart Valve in patients with severe aortic stenosis who are not good candidates for traditional surgery. The study compares this new device against commercially available transcatheter valves using transfemoral (through the leg) and alternative delivery methods.

How Is the Trial Designed?

Group I: Randomized IDE Cohort, Portico Valve Experimental Treatment 1 Intervention

Portico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING.

Group II: Nested Valve-in-Valve Registry Experimental Treatment 1 Intervention

Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve Status: ACTIVE, ENROLLING.

Group III: FlexNav Delivery System Study Experimental Treatment 1 Intervention

Portico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING

Group IV: Randomized IDE Cohort, CAV Active Control 1 Intervention

Any FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.

Portico Re-sheathable Transcatheter Aortic Valve System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Portico with FlexNav TAVR System for:

• Severe symptomatic aortic stenosis in high-risk and extreme-risk patients

Approved in European Union as Portico Transcatheter Aortic Valve System for:

• Severe symptomatic aortic stenosis in high-risk and extreme-risk patients

Approved in Canada as Portico Transcatheter Aortic Valve System for:

• Severe symptomatic aortic stenosis in high-risk and extreme-risk patients

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

The self-expanding Portico valve demonstrated comparable hemodynamic performance to the balloon-expandable SAPIEN XT valve in a study of 22 patients, with no significant differences in transaortic gradients or effective orifice areas after one month.

Both valves showed similar rates of severe prosthesis-patient mismatch and paravalvular leaks, indicating that the Portico valve is a safe alternative for patients with severe aortic stenosis and small annuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance. Del Trigo, M., Dahou, A., Webb, JG., et al.[2017]

The Portico system is a self-expanding valve prosthesis designed for transcatheter aortic valve replacement (TAVR), which is a minimally invasive procedure for patients with aortic valve stenosis.

The abstract outlines a 10-step implantation procedure for the Portico system, providing practical tips based on the authors' personal experiences to enhance the success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember. Tzikas, A., Amrane, H., Bedogni, F., et al.[2018]

The Portico TAVI system demonstrated significant and lasting improvements in aortic valve function in high-risk patients with severe aortic stenosis, with a low all-cause mortality rate of 3.6% at 30 days and 13.8% at 1 year among 222 patients studied.

At 1 year, 74.8% of patients showed improvement in their functional status, indicating that the Portico TAVI system is both safe and effective for treating severe aortic stenosis in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Linke, A., Holzhey, D., Möllmann, H., et al.[2019]

In a study of 90 high-risk patients with severe aortic stenosis, the Portico transcatheter aortic valve implantation (TAVI) showed a high procedural success rate of 97.8% and low all-cause mortality rates of 4.4% at 1 month, 6.7% at 12 months, and 7.8% at 24 months.

The procedure demonstrated significant improvements in echocardiographic measurements, such as reduced aortic valve peak velocity and pressure gradients, indicating its efficacy in alleviating symptoms and improving heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry. Didagelos, M., Ninios, V., Kakderis, C., et al.[2023]

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]

The Portico TAVI system is designed to reduce complications seen with first-generation transcatheter heart valves, offering a potentially safer option for patients undergoing aortic valve replacement.

This review includes a detailed description of the Portico system's implantation technique and summarizes clinical results from a single-center experience, highlighting its effectiveness in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Portico transcatheter aortic valve for the treatment of severe aortic stenosis. Taramasso, M., Miura, M., Gavazzoni, M., et al.[2019]

In a study of 1001 high-risk patients with severe aortic stenosis, the Portico™ transcatheter heart valve (THV) was successfully implanted in 97.5% of cases, demonstrating high procedural success.

At 30 days post-implantation, the Portico™ THV showed low rates of adverse events, including 2.6% all-cause mortality and 1.8% disabling stroke, while also improving hemodynamic performance with an effective orifice area of 1.82 cm².

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. Mollmann, H., Linke, A., Nombela-Franco, L., et al.[2022]

The Portico transcatheter aortic heart valve shows a low postprocedural mortality rate of 2.32% and overall device success in 95.82% of patients, indicating its safety and efficacy for high-risk patients with severe aortic stenosis.

In a review of 7 studies involving 2782 patients, common complications included a 2.23% stroke rate and 15.73% need for permanent pacemaker implantation, suggesting that while the valve is effective, careful monitoring for these complications is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural safety of transcatheter aortic valve replacement with Portico valve: a systematic review. Jaiswal, V., Wajid, Z., Suresh, V., et al.[2023]

The FlexNav delivery system for the Portico transcatheter heart valve has a reduced insertion profile, enabling access through smaller blood vessels (down to 5.0 mm), which enhances procedural safety.

Clinical data shows that the FlexNav system provides an excellent safety profile during procedures and up to 30 days post-implantation, potentially improving deployment accuracy and reducing the need for permanent pacemakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved transfemoral accessibility and positioning of the Portico transcatheter heart valve with the new FlexNav delivery system. Casenghi, M., Rubbio, AP., Marco, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307911/

One-Year Results of the Portico Transcatheter Aortic Heart ... The FlexNav DS was shown to be safe for the delivery of the Portico valve, which demonstrated sustained treatment benefits at 1 year with low rates of all-cause ...

2. acc.org acc.org/latest-in-cardiology/clinical-trials/2019/09/24/23/44/portico

Portico Re-sheathable Transcatheter Aortic Valve System ... The results of this trial indicate that TAVR with the self-expanding Portico valve met criteria for noninferiority for safety and efficacy ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1443950622011246

30-Day Outcomes With the Portico Transcatheter Heart Valve The current study provides insight into the outcomes associated with the use of the Portico THV in a contemporary real-world patient setting.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10455755/

One-Year Data from a Single-Center Experience - PMC We aimed to present one-year real-life data regarding TAVR procedures using Portico transcatheter heart valves (THVs) with new-generation, low-profile FlexNav ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/15/NCT02000115/Prot_000.pdf

PorticoTM Re-sheathable Transcatheter Aortic Valve ... effectiveness data on the SJM Portico Transcatheter Aortic Heart Valve and Delivery System following completion of enrollment of subjects in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651300/

Procedural safety of transcatheter aortic valve replacement ... This very first systematic review shows that transcatheter aortic valve replacement with the Portico valve appears to be safe and effective with low mortality ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772930322006020

One-Year Results of the Portico Transcatheter Aortic Heart ... The FlexNav DS was shown to be safe for the delivery of the Portico valve, which demonstrated sustained treatment benefits at 1 year with low rates of all- ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190023B.pdf

P190023 SSED - accessdata.fda.gov System consists of 3 components: (1) Portico Transcatheter Aortic Heart Valve. (Portico valve), (2) FlexNav Delivery System (DS), and (3) FlexNav Loading System.

9. jacc.org jacc.org/doi/10.1016/j.jcin.2020.06.041

Safety Profile of an Intra-Annular Self-Expanding ... Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days. Transcatheter aortic valve replacement (TAVR) is the ...