TY - JOUR
T1 - Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial
AU - Singh, Jagmeet P.
AU - Abraham, William T.
AU - Auricchio, Angelo
AU - Delnoy, Peter Paul
AU - Gold, Michael
AU - Reddy, Vivek Y.
AU - Sanders, Prashanthan
AU - Lindenfeld, Jo Ann
AU - Rinaldi, Christopher A.
N1 - Funding Information:
Funding for this study has been provided by EBR Systems, Inc. (Sunnyvale, CA, USA). The authors would like to thank Mark Schwartz, Spencer Kubo, Christopher Pfaff and Allan Will from EBR Systems for their assistance in the design of this study and drafting and editing this manuscript.
PY - 2019/11
Y1 - 2019/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85071283916&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2019.04.002
DO - 10.1016/j.ahj.2019.04.002
M3 - Article
C2 - 31472360
AN - SCOPUS:85071283916
VL - 217
SP - 13
EP - 22
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -