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The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial Impact of stent deformity induced by the kissing balloon technique for bifurcating lesions on in-stent restenosis after coronary intervention Outcomes with drug-coated balloons in small-vessel coronary artery disease Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study Treatment of Drug-Eluting Stent In-Stent Restenosis With Drug-Eluting Balloons: A Systematic Review and Meta-Analysis Drug-Coated Balloons: A Safe and Effective Alternative to Drug-Eluting Stents in Small Vessel Coronary Artery Disease

Clinical Trial2008 Oct;156(4):641-648.e1.

JOURNAL:Am Heart J. Article Link

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

Abraham WT, , FIX-HF-5 Investigators and Coordinators. Keywords: QRS duration; exercise tolerance; heart failure; peak Vo(2); quality of life

ABSTRACT


Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.