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.
journal_name
Am Heart Jjournal_title
American heart journalauthors
Singh JP,Abraham WT,Auricchio A,Delnoy PP,Gold M,Reddy VY,Sanders P,Lindenfeld J,Rinaldi CAdoi
10.1016/j.ahj.2019.04.002subject
Has Abstractpub_date
2019-11-01 00:00:00pages
13-22eissn
0002-8703issn
1097-6744pii
S0002-8703(19)30081-Xjournal_volume
217pub_type
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journal_title:American heart journal
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更新日期:1988-01-01 00:00:00
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doi:10.1016/j.ahj.2008.10.019
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pub_type: 杂志文章,多中心研究,随机对照试验
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pub_type: 杂志文章
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pub_type: 杂志文章,评审
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pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2017-07-01 00:00:00
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