Progress and collaboration on clinical trials

By: Barbara D. Buch, M.D. There are few responsibilities at FDA more important than reviewing the design and outcomes of clinical trials. Understanding the science behind the trials — and the individuals included in them — helps us to ensure that the medical products we approve are safe and effective. Last year, FDA took important steps to support the inclusion of diverse populations in clinical trials. Following Congress’s directive in Section 907 of the Food and Drug Administration Safety and Innovation Act, FDA is looking more closely at the sex, age, and race/ethnicity data that are collected in clinical trials. In August, FDA published an Action Plan designed to address three specific priorities: improving thequality and comprehensiveness of demographic subgroup data collection, reporting and analysis; identifying and eliminating barriers for increasedparticipation in clinical trials; and improving thetransparency of subgroup data. We’ve come far in achieving this plan. As we begin 2016, I want to outline our progress in preparation for the next important milestone: a public meeting on this topic on February 29. Priority 1 – Quality FDA updated and/or finalized relevant guidance on demographic subgroup data, as illustrated by these two examples of FDA staff training and/or outreach to external stakeholders: Integrated Summary of Effectiveness: Guidance for Industry Evaluation of Sex-Specific Data in Medical Device Clinical Studies, which...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog FDA Source Type: news

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The long-term effect of tricuspid regurgitation (TR) after device implantation on long-term mortality remains unknown. In the present study, we sought to examine whether patients undergoing an implantable cardiac device procedure (pacemaker, cardiac defibrillator or cardiac resynchronisation therapy) have an increased risk of TR and to determine the effect of this on long-term survival.
Source: International Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Providers should be aware of the possibility of cardiac resynchronization therapy ‐related proarrhythmia which could be life‐threatening. His‐bundle pacing may serve as an alternative, more physiological, option in the management as it preserves the normal sequence of depolarization from the septum to the lateral wall, and from endocardium to epicardium. AbstractProviders should be aware of the possibility of cardiac resynchronization therapy ‐related proarrhythmia which could be life‐threatening. His‐bundle pacing may serve as an alternative, more physiological, option in the management as it preserves the nor...
Source: Clinical Case Reports - Category: General Medicine Authors: Tags: CASE REPORT Source Type: research
Source: Journal of Nuclear Cardiology - Category: Nuclear Medicine Source Type: research
AbstractPurpose of reviewIn this review article, we aim to describe the pathophysiology of concomitant atrial fibrillation and both left and right heart failure, as well as pronounce the prognosis of having these two conditions simultaneously. This review also summarizes the current management of atrial fibrillation including stroke and thromboembolism prevention in the presence of systolic and diastolic heart failure.Recent findingsWhile rhythm control strategy is not superior to rate control strategy in atrial fibrillation patients without heart failure, catheter ablation for atrial fibrillation has shown to improve outc...
Source: Current Treatment Options in Cardiovascular Medicine - Category: Cardiology Source Type: research
ConclusionsIn CRT devices with left ventricular sensing, LA signal could be detected and used to estimate IACT especially if long ‐spaced electrodes are used.This article is protected by copyright. All rights reserved
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
Myocardial scarring is associated with non-response to cardiac resynchronization therapy (CRT) and conduction delay. Little is known about the significance and cause of left ventricular (LV) paced conduction disturbance (LPCD).
Source: Heart Rhythm - Category: Cardiology Authors: Source Type: research
Recent studies suggest that circulating endothelial progenitor cells (EPCs) may influence the response to cardiac resynchronization therapy (CRT). The aim of this study was to evaluate the effect of CRT on EPC...
Source: Stem Cell Research and Therapy - Category: Stem Cells Authors: Tags: Research Source Type: research
CONCLUSIONS: Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization. PMID: 32448844 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
AbstractPurpose of ReviewBiomarkers of cardiac fibrosis closely track the disease state that gives rise to heart failure. The purpose of this review is to highlight recent data on the use of soluble ST2, galectin-3, and procollagen, three markers of cardiac fibrosis, for aiding with prognostication, and to explore the use of these biomarkers for guiding therapy.Recent FindingsSoluble ST2, galectin-3, and procollagen are prognostic in both acute and chronic heart failure, and data are emerging as to their potential uses for guiding therapies. Mortality benefit from exercise, cardiac resynchronization therapy, statin use, as...
Source: Current Cardiology Reports - Category: Cardiology Source Type: research
Abstract Background: Approximately 20-40% of recipients of cardiac resynchronization therapy (CRT) do not respond to it based on the current patient selection criteria. The purpose of this study was to identify baseline parameters that can predict CRT response and to evaluate the effect of those predictive parameters on long-term prognosis. Methods: This was a retrospective, nonrandomized, noncontrolled cohort study. Patients who received CRT in our centre were divided into responders and nonresponders by the definition of CRT response (an increase in left ventricular ejection fraction (LVEF) of ≥5% and im...
Source: Cardiology Research and Practice - Category: Cardiology Authors: Tags: Cardiol Res Pract Source Type: research
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