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

Jagmeet P Singh; Mary Norine Walsh; Spencer H Kubo; Angelo Auricchio; Peter Paul Delnoy; Michael R Gold; Prashanthan Sanders; JoAnn Lindenfeld; Christopher A Rinaldi; Steven Ullery

doi:10.1016/j.ahj.2021.02.008

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

Am Heart J. 2021 May:235:158-162. doi: 10.1016/j.ahj.2021.02.008. Epub 2021 Feb 15.

Authors

Affiliations

¹ Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: jsingh@mgh.harvard.edu.
² St Vincent's Heart Center, Indiannapolis IN.
³ EBR Systems, Inc, Sunnyvale, CA.
⁴ Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
⁵ Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.
⁶ Cardiology Division, Medical University of South Carolina, Charleston, SC.
⁷ Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Australia.
⁸ Section of Heart Failure and Cardiac Transplantation, Vanderbilt Heart and Vascular Institute, Nashville, TN.
⁹ King's College Cardiology Department Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.
¹⁰ Namsa, Contract Research Organization, Minneapolis.

PMID: 33596412
DOI: 10.1016/j.ahj.2021.02.008

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.

Publication types

Clinical Trial Protocol

MeSH terms

COVID-19* / epidemiology
Cardiac Resynchronization Therapy* / adverse effects
Cardiac Resynchronization Therapy* / methods
Double-Blind Method
Endocardium*
Heart Failure* / therapy
Humans
Multicenter Studies as Topic
Pandemics*
Prospective Studies
Randomized Controlled Trials as Topic
Sample Size
Time Factors
Treatment Outcome
Ventricular Function, Left