Portico Valve for Aortic Stenosis

(PORTICO-IDE Trial)

Recruiting at 69 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

1242 Participants Needed

Trial Summary

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 data supports the idea that Portico Valve for Aortic Stenosis is an effective treatment?

The available research shows that the Portico Valve is an effective treatment for aortic stenosis. A study on the Portico Valve's use in real-world settings found positive outcomes two years after the procedure. Another study highlighted the system's design improvements over earlier valve systems, which help reduce complications. Additionally, a comparison study showed promising results for the Portico Valve's performance against another valve system, the SAPIEN XT, in patients with small aortic annuli. These findings suggest that the Portico Valve is a reliable option for treating aortic stenosis. ^{1 2 3 4 5}

What data supports the effectiveness of the Portico Valve treatment for aortic stenosis?

Research shows that the Portico Valve, used in transcatheter aortic valve implantation (TAVI), has been successful in treating patients with severe aortic stenosis, with positive outcomes observed up to two years after the procedure. The system is designed to address complications seen with earlier valve models, and studies have reported promising results in terms of its performance and safety. ^{1 2 3 4 5}

What safety data is available for the Portico Valve for Aortic Stenosis?

The Portico Valve has been evaluated in several studies. The CONFIDENCE registry, involving 1001 subjects, reported a 30-day all-cause mortality rate of 2.6%, cardiovascular mortality of 2.1%, and disabling stroke rate of 1.8%. A new pacemaker was needed in 19% of subjects. Another study with 169 patients using the FlexNav delivery system showed a 30-day all-cause mortality rate of 4.7% and a 1-year rate of 10.7%. The FlexNav system has improved procedural safety and accuracy, with a low rate of moderate paravalvular leak and permanent pacemaker implantation. However, a systematic review noted that there is still limited conclusive evidence on post-procedure safety outcomes. ^{4 6 7 8 9}

Is the Portico Valve for Aortic Stenosis safe for humans?

The Portico Valve has shown low rates of safety events in studies, with successful implantation in most cases and low mortality and stroke rates at 30 days. However, some patients required a new pacemaker, and there were moderate rates of vascular complications and kidney injury. ^{4 6 7 8 9}

Is the Portico Transcatheter Aortic Valve System a promising treatment for aortic stenosis?

Yes, the Portico Transcatheter Aortic Valve System is a promising treatment for aortic stenosis. It is a new type of heart valve that can be placed without open-heart surgery, which is helpful for patients who are at high risk for surgery. The Portico valve is self-expanding, meaning it can adjust itself to fit well in the heart, and it can be repositioned if needed during the procedure. Studies have shown that it works well in patients with severe aortic stenosis, and it has been used successfully in real-world settings. ^{1 2 3 4 6}

How is the Portico Valve treatment different from other treatments for aortic stenosis?

The Portico Valve is unique because it is a self-expanding, resheathable, and repositionable transcatheter valve, which allows for adjustments during the procedure, unlike some other valves that are balloon-expandable and not repositionable. This feature can potentially improve the precision and safety of the valve placement in patients with severe aortic stenosis. ^{1 2 3 4 6}

What is the purpose of this trial?

This trial is testing a new heart valve replacement device for patients with severe heart valve issues who are too high-risk for traditional surgery. The device is inserted through a blood vessel, making the procedure less invasive.

Research Team

Raj Makkar

Principal Investigator

Cedars-Sinai Medical Center

Gregory Fontana, M.D.

Principal Investigator

Los Robles Regional Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. Spain 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. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry. [2023]

3. United States 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. [2019]

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

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember. [2018]

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

The Portico transcatheter aortic valve for the treatment of severe aortic stenosis. [2019]

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

Procedural safety of transcatheter aortic valve replacement with Portico valve: a systematic review. [2023]

7. Switzerland 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. [2022]

8. 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]

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

Improved transfemoral accessibility and positioning of the Portico transcatheter heart valve with the new FlexNav delivery system. [2021]