Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)

NCT02027883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-05-22

Study results available
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Summary

As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is crucial. Multiple induction attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting the number of attempts will allow for better lead stability throughout the procedure and a more straightforward implant process.

Investigator proposes a detailed documentation of success rates from various Ventriculart Fibrillation induction methods during implant of Medtronic defibrillation capable devices.

Conditions

Interventions

DEVICE

Nominal T shock setting

Nominal Parameter Set 1 Programming Values for EnTrust

DEVICE

Educated T shock setting

Experimental Parameter Set 2 Programming Values

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY
  • James Merrill

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02027883 on ClinicalTrials.gov