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Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead

NCT03110627 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2021-04-30

No results posted yet for this study

Summary

This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Conditions

Interventions

DEVICE

VDD ICD (experimental group)

Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

DEVICE

Single chamber VVI ICD (control group)

Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Sponsors & Collaborators

  • Applied Health Research Centre

    collaborator OTHER

  • Biotronik Canada Inc

    collaborator INDUSTRY

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Eugene Crystal, MD, FRCP(C) · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03110627 on ClinicalTrials.gov