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Device Replacement clinical trials

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NCT ID: NCT02323503 Completed - Device Replacement Clinical Trials

Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

BioCONTINUE
Start date: June 9, 2015
Phase:
Study type: Observational [Patient Registry]

Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

NCT ID: NCT02076789 Recruiting - Device Replacement Clinical Trials

DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry

DECODE
Start date: March 2013
Phase: N/A
Study type: Observational

This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.

NCT ID: NCT00395447 Completed - Clinical trials for Postoperative Complications

REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

REPLACE
Start date: July 2007
Phase: Phase 4
Study type: Observational

The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.