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itemprop="name">Aortic Stenosis</span> Studies </a> <meta itemprop="position" content="2"></li><li class="active">This trial</li></ol><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/aortic-stenosis", "name": "Aortic Stenosis" } }] } </script><script type="application/ld+json"> { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "item": { "@id": "https://clinicaltrials.ucsf.edu/", "name": "UCSF Clinical Trials" } },{ "@type": "ListItem", "position": 2, "item": { "@id": "https://clinicaltrials.ucsf.edu/heart-failure", "name": "Heart Failure" } }] } </script></div> <div><div class="d-none d-md-block navbar-text"><form method="GET" action="https://clinicaltrials.ucsf.edu/" class="form-inline my-1" role="search"> <label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../aortic-stenosis">Aortic Stenosis</a></span><span class="comma-list-item"> <a href="../heart-failure">Heart Failure</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 18 years and up</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2016-09-01">September 2016</time></span></div><div> completion around <time datetime="2025-02-28">February 2025</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2016-01-22"></div></dd></dl></div> </div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)</p><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../aortic-stenosis" class="trial--link-to-condition-in-text">Aortic Valve Stenosis</a></span>, <span> Valve</span>, <span> <a href="../heart-failure" class="trial--link-to-condition-in-text">Heart Failure</a></span>, <span> SAPIEN 3 THV</span>, <span> Optimal Heart Failure Therapy</span>, <span> OHFT</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><p>All candidates for this study must meet all of the following inclusion criteria:</p><ol><li>Age ≥18 years</li><li>Heart Failure with NYHA class ≥ 2</li><li><p>Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization.</p><p> Note: Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for <a href="../heart-failure" class="trial--link-to-condition-in-text">heart failure</a>. (12, 13) Patients with <a href="../aortic-stenosis" class="trial--link-to-condition-in-text">aortic stenosis</a> may not be able to tolerate maximal doses of heart failure medications and no specific guidelines exist for the medical treatment of heart failure in the setting of aortic stenosis. It is expected that the heart failure PI will review the medical therapy and confirm that it is appropriate for the patient's condition.</p></li><li><p>Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) >1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS is suspected when the an AVA > 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA<1.0 cm2 but with an indexed AVA of >0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients with AVA >1.5 cm2 but with indexed AVA<0.9 cm2/m2 on either rest of DSE are also eligible.</p><p> Note: Typically such cases will demonstrate,</p><p> • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valve area (AVA) > 1.0 cm2 and ≤1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest</p><p> OR</p><p> • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg and aortic valve area (AVA) ≤1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA)</p><p> •>1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) with low dose dobutamine stress echo (DSE).</p><p> In atypical cases (for example mean gradient is below 20 mmHg but valve area is consistent with moderate AS, the final eligibility determination in regards to diagnosis of moderate AS will be made by the echocardiographic core lab.</p></li><li>Left ventricular (LV) ejection fraction (EF) < 50% at rest</li><li>Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV</li><li>Able to provide independent informed consent (i.e., not requiring a legally authorized representative)</li></ol></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><p>Candidates are excluded from the study if any of the following conditions are present:</p><ol><li>LVEF < 20% or persistent need for intravenous inotropic support</li><li>Hospitalization for acute decompensated HF within 2 weeks prior to randomization</li><li>Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization</li><li>Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization</li><li>In need and suitable for revascularization per heart team consensus</li><li>Severe aortic and/or <a href="../mitral-valve-insufficiency" class="trial--link-to-condition-in-text">mitral regurgitation</a></li><li>Congenital unicuspid or congenital bicuspid aortic valve</li><li>Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA)</li><li>Previous aortic valve replacement (mechanical or bioprosthetic)</li><li>Severe RV dysfunction</li><li>Previous stroke with permanent disability (modified Rankin score ≥ 2)</li><li>Severe <a href="../lung-disease" class="trial--link-to-condition-in-text">lung disease</a> as indicated by FEV1 <30% predicted or need for chronic daytime supplemental oxygen therapy</li><li>Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy</li><li>Gastrointestinal (GI) bleeding within the past 3 months</li><li>Liver <a href="../cirrhosis" class="trial--link-to-condition-in-text">cirrhosis</a> Child-Pugh C</li><li>Active systemic infection, including active endocarditis</li><li>Unwilling to accept blood transfusion</li><li>Evidence of intracardiac mass, thrombus or vegetation</li><li>Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV</li><li>Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in <a href="../atrial-fibrillation" class="trial--link-to-condition-in-text">atrial fibrillation</a>)</li><li>Sensitivity to contrast media which cannot be adequately pre-medicated</li><li>Women of child-bearing potential</li><li>Clinical signs of <a href="../dementia" class="trial--link-to-condition-in-text">dementia</a></li><li>Other medical, social, or psychological conditions that precludes appropriate consent and follow-up</li><li>Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases</li><li>Unwillingness to undergo follow-up investigations</li><li>Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries)</li></ol></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94143</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">University of Southern California - Los Angeles</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Los Angeles</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 90033</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2016-09-01">September 2016</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2025-02-28">February 2025</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Cardiovascular Research Foundation, New York</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT02661451" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT02661451</a> </dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">About 178 people participating</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2023-07-14">July 2023</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block 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