Jagmeet P Singh1, William T Abraham2, Angelo Auricchio3, Peter Paul Delnoy4, Michael Gold5, Vivek Y Reddy6, Prashanthan Sanders7, JoAnn Lindenfeld8, Christopher A Rinaldi9. 1. Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: jsingh@mgh.harvard.edu. 2. Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. 3. Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland. 4. Department of Cardiology, Isala Hospital, Zwolle, The Netherlands. 5. Cardiology Division, Medical University of South Carolina, Charleston, SC. 6. Cardiac Arrhythmia Service, Mount Sinai Medical Center, NY, New York. 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. Division of Imaging Sciences and Biomedical Engineering, King's College Cardiology Department, Guys and St Thomas' NHS Foundation Trust, London, SE1 7EH, United Kingdom; Cardiology Department, Guys and St Thomas' NHS Foundation Trust, London, SE1 7EH, United Kingdom.
Abstract
BACKGROUND:Cardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems. A new wireless endocardial left ventricular (LV) pacing system allows CRT without such limitations and has shown promise in open-label studies. The purpose of this study is to evaluate its use in a patient population with poor therapeutic alternatives. METHODS: The SOLVE CRT study is an international, multi-center, randomized, double-blind, sham-controlled trial of patients with Class I and IIa indications for CRT who have either failed to respond to or have been unable to receive conventional CRT. Enrollment will comprise 350 patients implanted with the wireless CRT system randomized 1:1 to therapy on (Treatment) or therapy off (Control) for the six-month period over which trial primary endpoints will be evaluated. The primary safety endpoint will measure the proportion of patients free from system- and procedure-related complications. Primary efficacy endpoints will assess absolute change in LV end-systolic volume LVESV, proportion of patients reducing LVESV by ≥15% and clinical composite score for Treatment versus Control patients. Primary endpoints will be evaluated on an intention-to-treat basis, though per-protocol and as-treated analysis will also be performed. CONCLUSION: SOLVE-CRT will quantify the safety and effectiveness of wireless CRT in non-responders to conventional CRT and indicated patients who have been unable to receive CRT via the usual transvenous approach.
RCT Entities:
BACKGROUND: Cardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems. A new wireless endocardial left ventricular (LV) pacing system allows CRT without such limitations and has shown promise in open-label studies. The purpose of this study is to evaluate its use in a patient population with poor therapeutic alternatives. METHODS: The SOLVE CRT study is an international, multi-center, randomized, double-blind, sham-controlled trial of patients with Class I and IIa indications for CRT who have either failed to respond to or have been unable to receive conventional CRT. Enrollment will comprise 350 patients implanted with the wireless CRT system randomized 1:1 to therapy on (Treatment) or therapy off (Control) for the six-month period over which trial primary endpoints will be evaluated. The primary safety endpoint will measure the proportion of patients free from system- and procedure-related complications. Primary efficacy endpoints will assess absolute change in LV end-systolic volume LVESV, proportion of patients reducing LVESV by ≥15% and clinical composite score for Treatment versus Control patients. Primary endpoints will be evaluated on an intention-to-treat basis, though per-protocol and as-treated analysis will also be performed. CONCLUSION: SOLVE-CRT will quantify the safety and effectiveness of wireless CRT in non-responders to conventional CRT and indicated patients who have been unable to receive CRT via the usual transvenous approach.
Authors: Baldeep S Sidhu; Justin Gould; Mark K Elliott; Vishal Mehta; Steven Niederer; Christopher A Rinaldi Journal: Arrhythm Electrophysiol Rev Date: 2021-04
Authors: Mark K Elliott; Vishal S Mehta; Baldeep Singh Sidhu; Steven Niederer; Christopher A Rinaldi Journal: Herz Date: 2021-10-25 Impact factor: 1.443