CIED Infection Quality Initiative Demonstration Project (RECTIFY)

Posted on July 14th, 2023
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The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.

Sponsored by Duke University

ClinicalTrials.gov ID: NCT05471973

Link to ClinicalTrials.gov for more information

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The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.

Sponsored by Duke University

ClinicalTrials.gov ID: NCT05471973

Link to ClinicalTrials.gov for more information

Extravascular ICD Pivotal Study (EV ICD)

Posted on July 14th, 2023
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The study enrolled subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects received an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed until regulatory approval is received.

Clinicaltrials.gov ID: NCT04060680

Link to clinicaltrials.gov for study description

Other resources:

Press release: Medtronic Extravascular ICD global clinical trial results reinforce device safety and effectiveness

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The study enrolled subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects received an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed until regulatory approval is received.

Clinicaltrials.gov ID: NCT04060680

Link to clinicaltrials.gov for study description

Other resources:

Press release: Medtronic Extravascular ICD global clinical trial results reinforce device safety and effectiveness

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