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Cardioverter Defibrillator Replacement With Induction of Ventricular Fibrillation and Defibrillation Testing

NCT02513030 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-10-19

No results posted yet for this study

Summary

The SIMPLE study was a large one, and lasted quite a few years due to its design as a randomized controlled trial and the follow up needed to reach an endpoint. The investigators aim to conduct an observational pilot study looking at frequency of positive findings during VF testing . The comparator will be the rate of findings during testing in the Simple trial. If the investigators will find an increased rate of findings (significantly higher than in the Simple trial ) it may set the stage for a randomized controlled trial of replacements , along the line of the Simple trial , or to a recommendation to continue VF testing in all ICD replacements.

Conditions

  • Defibrillation Capacity of Defibrilators After Replacement

Interventions

PROCEDURE

Defibrillation testing during ICD replacement

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-03-31
Completion
2018-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513030 on ClinicalTrials.gov