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Medical research helps improve patient care. Researchers look for new treatments and evaluate new and improved technologies, procedures and medical devices, such as heart valves and stents. A clinical trial (a research study that uses human participants, often the last phase of a research project) is an important research step that helps the U.S. Food and Drug Administration determine whether these advancements will be made available to the general public.
Structural Heart and Valve Disease Research
Swedish is one of the leading clinical trial sites in the western United States. Because the Structural Heart and Valve Disease team members at the Swedish Heart & Vascular Institute (SHVI) are national and international leaders in their areas of expertise, they often participate in clinical trials. Many of those clinical trials are only available at Swedish.
It is a privilege to make clinical trials available to our patients. It allows us to consider therapies that may not yet be widely available. Clinical trials are carefully regulated by Federal and State agencies. Participation in a clinical trial depends on a lot of factors, including strict eligibility requirements. These requirements support our goal of keeping our patients’ best interests in mind and our mission to provide the right therapy for the right patient at the right time. Once eligibility is determined, however, the final decision to participate in a clinical trial is personal and voluntary, and patients may withdraw from participation at any time.
If you are interested in learning more about clinical trial participation please call 206-215-1500.
Structural Heart and Valve Disease Research Highlights
Aortic Valve Research Trials
Mitral Valve Research Trials
Congenital Trials
Left Atrial Appendage Occluder Trials
Tricuspid Valve Trials
Cerebral Protection Trials
Access Management Trials
Aortic Valve Research Trials
Medtronic Low-Risk TAVR Trial: This is a randomized evaluation of the safety and effectiveness of Medtronic’s CoreValve™ Evolut™ R and Evolut™ PRO transcatheter aortic valve replacement (TAVR) device in patients with severe aortic stenosis and at low risk for surgery. The device is investigational for this indication. Participants will be followed for up to 10 years. Swedish Medical Center is the only site in Washington area enrolling in this trial.
PORTICO: This is a randomized evaluation of the safety and efficacy of Abbott’s PORTICO™ transcatheter aortic valve replacement (TAVR) device, an investigational device in patients with severe aortic stenosis at high and prohibitive risk for surgery.
REPRISE III: This is a randomized evaluation of the safety and efficacy of Boston Scientific’s LOTUS™ transcatheter aortic valve replacement (TAVR) device, an investigational device in patients with severe aortic stenosis at high and prohibitive risk for surgery.
Mitral Valve Research Trials
COAPT: Randomized evaluation of the safety and efficacy of Abbott’s MitraClip® device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. The device is investigational for this indication. Swedish Medical Center is the only site in Washington area enrolling in this trial.
TMVR: This is a randomized evaluation of the safety and efficacy of a transcatheter mitral valve replacement trial system for patients with significant mitral valve disease.
Congenital Trials
PFO REGISTRY: This is a post-market registry of the Amplatzer ™ PFO occluder device in patients with cryptogenic stroke.
CORVIA: This trial, known as REDUCE-LAP HF II, is a randomized evaluation of the safety and efficacy of the Corvia™ interatrial shunt device to treat left atrial pressure in patients with heart failure. Participants must have significant heart failure symptoms, age more than 40 years of age, LVEF > 40%, and elevated left atrial pressure. The device is investigational. Participants will be followed for one year.
Left Atrial Appendage Occluder Trials
AMULET: This is a randomized evaluation of the safety and effectiveness of Abbott’s AMPLATIZER™ Amulet™ left atrial appendage (LAA) occluder device, an investigational device to reduce the risk of thromboembolism from the LAA in patients with non-valvular atrial fibrillation (AF) who are at increased risk for stroke and systemic embolism. Participants must be recommended for anticoagulation therapy, deemed by physician to be suitable for warfarin, and have appropriate rationale to seek a non-pharmacologic alternative to warfarin or other anticoagulation therapy. Participants will be followed up through five years.
Tricuspid Valve Trials
TRIALIGN: This is a feasibility evaluation of the safety and performance of the Mitralign™ percutaneous tricuspid valve annuloplasty system for treatment of symptomatic chronic functional tricuspid regurgitation. Participants must be over 18 years of age, with LVEF > 34%, be symptomatic despite guideline-directed medical therapy, and fit anatomic criteria based on echocardiographic and computerized tomography imaging.
NAVIGATE: This is a compassionate use option for use of the Navigate valve in patients without other treatment options.
Cerebral Protection Trials
REFLECT: This is a randomized evaluation of the safety and effectiveness of Keystone Heart’s TriGuard™ embolic deflection device, an investigational device to reduce the impact of cerebral embolic lesions after TAVR implantation. The study is a prospective, single-blind, randomized multicenter trial at up to 30 investigational sites. All participants will be followed clinically in-hospital and at up to 90 days using a combination of neurologic and neuropsychological testing as well as diffusion-weighted MRI. The device is investigational. Swedish Medical Center is the only site in the Washington area enrolling in this trial.
Access Management Trials
MANTA: This is a randomized evaluation of the safety and efficacy of the Manta closure device, an investigational device to deal with closure of large-bore femoral arterial access. The device is investigational.