{"id":6476,"date":"2026-02-03T05:25:40","date_gmt":"2026-02-03T05:25:40","guid":{"rendered":"https:\/\/www.heart-valve-surgery.com\/learning\/?page_id=6476"},"modified":"2026-03-03T16:50:29","modified_gmt":"2026-03-03T16:50:29","slug":"believers-trial-tavr-bicuspid-aortic-patients","status":"publish","type":"page","link":"https:\/\/www.heart-valve-surgery.com\/learning\/believers-trial-tavr-bicuspid-aortic-patients\/","title":{"rendered":"The BELIEVERS Clinical Trial to Evaluate TAVR for Bicuspid Aortic Valve Patients"},"content":{"rendered":"<p>The safety and efficacy of transcatheter aortic valve replacement (TAVR) for aortic stenosis has been demonstrated thanks to several clinical trials conducted over the past decade. Unfortunately, these research studies only included patients with calcified tricuspid aortic valves. Patients with bicuspid aortic valves were not included in these studies.<\/p>\n<p>However\u2026 There is promising news for patients with bicuspid aortic valve stenosis, thanks to the launch of a unique research study known as the BELIEVERS Clinical Trial at Cedars-Sinai Medical Center in Los Angeles, California. To learn more about this study, Adam Pick, the patient who founded HeartValveSurgery.com, spoke with <a href=\"https:\/\/www.heart-valve-surgery.com\/interventional-cardiologist\/dr-Aakriti-Gupta-Los+Angeles-California.php\">Dr. Aakriti Gupta,<\/a> a leading interventional cardiologist at Cedars-Sinai. Dr. Gupta is a co -principal investigator on the BELIEVERS trial.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/88FW7SIq-HA?rel=0&amp;si=iMPs6mrLcGCQYEbH\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p>&nbsp;<\/p>\n<h2>Key Facts About the BELIEVERS Clinical Trial<\/h2>\n<p>Here are the key insights shared by Dr. Gupta:<\/p>\n<ul>\n<li>Past TAVR clinical trials and the exclusion of bicuspid aortic valve patients. \u201cFirst, I want to lay the foundation by stating that TAVR was approved for aortic stenosis through very rigorous randomized clinical trials,\u201d said Dr. Gupta. \u201cSurgery used to be the go-to option but to prove that we can perform TAVR and it\u2019s going to be safe and feasible, we had a multitude of randomized controlled trials showing TAVR was as good as surgery. But, a very important detail there is that patients with bicuspid aortic stenosis were excluded from those trials. So, we do not have state-of-the-art evidence to prove that TAVR is a feasible option for patients with bicuspid aortic stenosis. There could be a chance that patients are incurring harm from having a TAVR instead of surgery. It\u2019s also possible that TAVR is better than surgery. We don\u2019t know because we don\u2019t have that evidence.\u201d<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6479 aligncenter\" src=\"https:\/\/www.heart-valve-surgery.com\/learning\/..\/Images\/bicuspid-aortic-valve-drawing-gupta.jpg\" alt=\"Bicuspid Aortic Valve Drawing\" width=\"650\" height=\"360\" \/><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Getting evidence through a clinical trial. Dr. Gupta explained that most hospitals in the country will only offer surgery for most 60-year-old patients with bicuspid aortic stenosis. \u201cI think to change that paradigm or to keep that paradigm, we want to produce the best evidence,\u201d she said. \u201cFor that, we are conducting the BELIEVERS Trial. The Patient Centers Outcome Research Institute (PCORI) is funding the trial with Dr. Raj Makkar as the principal investigator. I am the co-investigator.\u201d<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6478 aligncenter\" src=\"https:\/\/www.heart-valve-surgery.com\/learning\/..\/Images\/believers-clinical-trial.jpg\" alt=\"BELIEVERS Clinical Trial\" width=\"650\" height=\"360\" \/><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>The BELIEVERS clinical trial process. \u201cThe trial will randomize patients with bicuspid aortic stenosis to either TAVR or surgery,\u201d Dr. Gupta said. \u201cWe will follow patients for up to 10 years and produce the long-term data needed to make an informed decision.\u201d Dr. Gupta pointed out that many patients prefer TAVR for its convenience. They can go home the day after a TAVR instead of having open heart surgery to repair their valve. \u201cIt should not just be based on convenience, but what is best in the long-term,\u201d she said. \u201cThat is what we are trying to do.\u201d<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Participants in the BELIEVERS clinical trial have a lot to gain and something to give. Dr. Gupta explained that patients should consider that they are not only part of the trial and getting treatment, but they are also contributing to the knowledge that will benefit thousands of patients after them. \u201cJust the way patients who participated in the previous trials helped to get TAVR approved in the first place, now more patients can benefit. I always tell my patients that they are going to add to the body of evidence and contribute to the field by being part of the trial.\u201d<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2>Thanks Dr. Gupta and Cedars-Sinai Medical Center!<\/h2>\n<p>On behalf of all the patients in our community, thank you, <a href=\"https:\/\/www.heart-valve-surgery.com\/interventional-cardiologist\/dr-Aakriti-Gupta-Los+Angeles-California.php\">Dr Aakriti Gupta<\/a>, for everything you and your team are doing at Cedars-Sinai Medical Center in Los Angeles, California!<\/p>\n<p>Related links:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/interventional-cardiologist\/dr-Aakriti-Gupta-Los+Angeles-California.php\">Find out more at Dr. Aakriti Gupta\u2019s Interactive Surgeon Profile<\/a><\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2024\/08\/28\/raj-makkar-cath-lab-tour\/\">Inside Access: The Heart Valve Catheter Lab at Cedars-Sinai<\/a><\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/learning\/tavr-aortic-regurgitation-aakriti-gupta-md\/\">Ask Dr. Gupta: What About TAVR for Aortic Regurgitation?<\/a><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Keep on tickin,<br \/>\nAdam<\/p>\n<p>P.S. For the deaf and hard-of-hearing members of our patient community, we have provided a written transcript of our interview with Dr. Gupta below.<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cms.php","meta":{"_acf_changed":false,"footnotes":""},"categories":[11],"class_list":["post-6476","page","type-page","status-publish","hentry","category-medical-technology"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/pages\/6476","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/comments?post=6476"}],"version-history":[{"count":6,"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/pages\/6476\/revisions"}],"predecessor-version":[{"id":6527,"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/pages\/6476\/revisions\/6527"}],"wp:attachment":[{"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/media?parent=6476"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/learning\/wp-json\/wp\/v2\/categories?post=6476"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}