Transcatheter Shunt System for Heart Failure
(ALT-FLOW II Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Edwards Lifesciences
Must be taking:GDMT for HFpEF/HFmrEF
Disqualifiers: Severe heart failure, Valve disease, RV dysfunction, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Will I have to stop taking my current medications?
The trial requires that participants stay on their current heart failure medications without change for 6 months before joining the study.
How is the Edwards APTURE Transcatheter Shunt System treatment different from other heart failure treatments?
The Edwards APTURE Transcatheter Shunt System is unique because it involves a minimally invasive procedure to create a shunt (a small passage) in the heart, which can help reduce pressure and improve symptoms in heart failure patients. This approach is different from traditional heart failure treatments that often rely on medications or more invasive surgeries.
12345Eligibility Criteria
This trial is for adults with heart failure who have been on stable heart medication for over a month, experienced at least one hospitalization due to heart failure in the past year, and show specific signs of lung congestion during exercise. They must not have severe kidney issues, recent strokes or infections, certain types of valve disease, very poor walking ability or extremely severe heart failure.Inclusion Criteria
My heart's pumping ability is reduced but not severely, and I have moderate to severe difficulty with physical activity.
I have heart failure that causes me symptoms.
I have been hospitalized for heart failure or have high BNP/NT-proBNP levels.
My heart test shows high lung pressure during exercise.
Exclusion Criteria
I have severe heart failure and cannot move around easily.
I have not had a stroke, TIA, DVT, or pulmonary embolus in the last 6 months.
My heart's right side is not working well, or I have signs of liver issues due to heart problems, or my BMI is 45 or more.
My kidney function is low, shown by high creatinine or low eGFR, or I am on dialysis.
I have moderate to severe heart valve disease.
I can walk less than 50 meters or more than 450 meters in six minutes.
Participant Groups
The ALT-FLOW II Trial is testing the Edwards APTURE transcatheter shunt system against a sham procedure (a fake operation that seems real) to see if it helps patients with heart failure. Participants are randomly chosen to receive either the actual device implantation or a pretend procedure without receiving the device.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APTURE shunt + medical therapyExperimental Treatment1 Intervention
Group II: Sham + medical therapyPlacebo Group1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California IrvineIrvine, CA
University of California San DiegoLa Jolla, CA
University of California San FranciscoSan Francisco, CA
Medical Center of the RockiesLoveland, CO
More Trial Locations
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
References
Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. [2019]The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position.
Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science. Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.
Transthoracic access for transcatheter aortic valve replacement: technique using the Edwards Sapien Retroflex delivery system. [2014]We describe our experience using the Edwards Sapien transfemoral Retroflex 3 catheter delivery system for transcatheter aortic valve replacement through the transapical and transaortic approaches. Transthoracic transcatheter valve replacement by the transapical and transaortic approaches can be safely and effectively performed with the Retroflex 3 delivery catheter, which affords several advantages over other available delivery devices.
Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. [2022]The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis.
First successful trans-catheter aortic valve implantation through ascending aorta using Edwards SAPIEN THV system. [2016]Trans-catheter aortic valve implantation is rapidly becoming an established modality of treatment for patients with critical aortic stenosis who are high risk for conventional aortic valve replacement. This approach also has its limitations; however, with growing experience and improvements in the delivery system, it may be possible to overcome these limitations. We describe a case where conventional trans-catheter approaches, that is, transfemoral or trans-apical using the Edwards THV system, were not possible but successful implantation was achieved through the trans-aortic route.