Portico Valve for Aortic Stenosis (PORTICO-IDE Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Abbott Medical Devices
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
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.
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.12379
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.25678
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.12349
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.
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
I have symptoms of aortic stenosis and my activity is somewhat to severely limited.
I am 21 years old or older.
Exclusion Criteria
My blood vessel near the shoulder is less than 6.7 inches from a specific point.
I have not had a serious heart infection in the last 6 months.
My heart valve is thickened and near the artery openings.
My aorta is heavily calcified, making certain heart procedures complicated.
I have a thickened heart muscle, with or without blockage.
I have severe kidney problems or am on long-term dialysis.
I do not have major aortic disease like large aneurysms or severe artery twists.
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 a history of bleeding or clotting disorders.
I have severe heart failure requiring medication or mechanical support.
I have a heart condition that hasn't been treated but needs surgery.
I need emergency surgery.
My heart's pumping ability is severely reduced.
My blood vessels in the hip area are not severely blocked or twisted, making it safe for certain medical procedures.
My aortic valve is either congenital unicuspid, bicuspid, or non-calcified.
I need medication or a device to help my heart pump blood.
I have severe aortic valve disease with more leakage than narrowing.
My heart's aortic opening is either smaller than 19 mm or larger than 27 mm.
I have a condition that makes heart access through the chest difficult.
My arteries near the shoulder are very narrow or twisted.
Treatment Details
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: Randomized IDE Cohort, Portico ValveExperimental Treatment1 Intervention
Portico transcatheter aortic valve and Portico delivery system.
Status: ACTIVE, NOT ENROLLING.
Group II: Nested Valve-in-Valve RegistryExperimental Treatment1 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 StudyExperimental Treatment1 Intervention
Portico transcatheter aortic valve and FlexNav delivery system
Status: ACTIVE, NOT ENROLLING
Group IV: Randomized IDE Cohort, CAVActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Albany Medical CenterAlbany, NY
Cedars-Sinai Medical CenterLos Angeles, CA
Winthrop University HospitalMineola, NY
Advocate Christ Medical CenterOak Lawn, IL
More Trial Locations
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
References
Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance. [2017]The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis.
Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember. [2018]The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.
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]The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS).
The Portico transcatheter aortic valve for the treatment of severe aortic stenosis. [2019]The Portico TAVI system (Abbott Vascular, Santa Clara, CA, USA) has been specifically designed to mitigate some of the complications associated with first-generation valves. Most of the data generated from randomized studies comparing transcatheter aortic valve implantation with surgery stem from reported experiences with first generation transcatheter heart valve devices. The aim of this review is to describe the repositionable and retrievable Portico system and its implantation technique, coupled with our single-center experience and to provide a review of the clinical results reported so far in the literature.
Improved transfemoral accessibility and positioning of the Portico transcatheter heart valve with the new FlexNav delivery system. [2021]The new iteration of the Portico transcatheter heart valve delivery system, the FlexNav, has been designed to enhance procedural safety and accuracy of the platform. Major technological advancements were the significant reduction of the insertion profile, allowing a transfemoral access down to 5.0 mm vessels, and the addition of a stability layer, improving deployment accuracy and thus potentially reducing implantation depth and permanent pacemaker implantation rate. Published data on patients undergoing Portico transcatheter heart valve implantation with the new FlexNav delivery system confirms excellent procedural and 30-day safety profile.
Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. [2022]A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.
Procedural safety of transcatheter aortic valve replacement with Portico valve: a systematic review. [2023]The Portico transcatheter aortic heart valve is a self-expandable, fully resheathable bioprosthetic valve with a nitinol frame and porcine pericardial sealing cuff. It has been used among symptomatic severe aortic stenosis (AS) who are at high or extreme surgical risk. However, till date very few studies has been reported with inconclusive evidence for its postprocedure safety outcomes.
Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience. [2023]Significant progress has been made in both valves and delivery systems (DSs) for transcatheter aortic valve replacement (TAVR) procedures. We aimed to present one-year real-life data regarding TAVR procedures using Portico transcatheter heart valves (THVs) with new-generation, low-profile FlexNav DSs. This retrospective, single-center study enrolled 169 consecutive patients (mean age: 75.8 years, 68% females) with severe aortic stenosis undergoing TAVR with Portico THVs and FlexNav DSs between 2020 and 2021. We evaluated safety and efficacy outcomes, following the VARC-3 consensus, periprocedurally and at 30 days and 1 year. Procedural success was observed in 95.9% of cases, and no procedural mortality occurred. At 30 days, the rates of all-cause mortality, cardiovascular mortality, and neurological events were 4.7%, 3.6%, and 3.0%, respectively. Additionally, major vascular complications, acute kidney injury, and bleeding were recorded at rates of 11.2%, 14.8%, and 7.7%, respectively. The 1-year data showed all-cause mortality, cardiovascular mortality, and neurological event rates of 10.7%, 8.3%, and 7.7%, respectively. The moderate paravalvular leak and permanent pacemaker rates at 1 year were 2.6% and 12.2%, respectively. This real-life data provided evidence of positive outcomes and high technical success with Portico THVs and FlexNav DSs. Furthermore, we found low rates of mortality and neurological events, with satisfactory hemodynamic and functional results.
Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry. [2023]The self-expanding, resheathable, repositionable transcatheter aortic heart valve Portico is being used successfully for transcatheter aortic valve implantation procedures (TAVI) in patients with severe aortic stenosis. The aim of this study was to evaluate outcomes at 2 years after TAVI with the Portico valve.