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Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial.
Singh, Jagmeet P; Walsh, Mary Norine; Kubo, Spencer H; Auricchio, Angelo; Delnoy, Peter Paul; Gold, Michael R; Sanders, Prashanthan; Lindenfeld, JoAnn; Rinaldi, Christopher A; Ullery, Steven.
  • Singh JP; Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: jsingh@mgh.harvard.edu.
  • Walsh MN; St Vincent's Heart Center, Indiannapolis IN.
  • Kubo SH; EBR Systems, Inc, Sunnyvale, CA.
  • Auricchio A; Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
  • Delnoy PP; Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.
  • Gold MR; Cardiology Division, Medical University of South Carolina, Charleston, SC.
  • Sanders P; Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Australia.
  • Lindenfeld J; Section of Heart Failure and Cardiac Transplantation, Vanderbilt Heart and Vascular Institute, Nashville, TN.
  • Rinaldi CA; King's College Cardiology Department Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.
  • Ullery S; Namsa, Contract Research Organization, Minneapolis.
Am Heart J ; 235: 158-162, 2021 05.
Article in English | MEDLINE | ID: covidwho-1139418
ABSTRACT
The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Endocardium / Cardiac Resynchronization Therapy / Pandemics / COVID-19 / Heart Failure Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am Heart J Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Endocardium / Cardiac Resynchronization Therapy / Pandemics / COVID-19 / Heart Failure Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am Heart J Year: 2021 Document Type: Article