Optimal EGM Configuration for Morphology Discrimination

NCT ID: NCT00888667

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.

Detailed Description

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Conditions

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Premature Ventricular Complexes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ICD patient with frequent PVCs

Pacing interventions

Intervention Type OTHER

10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting

Interventions

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Pacing interventions

10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
2. Patients must be willing to sign an informed consent form.
3. Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria

1. Known history of slow VT (under 160 bpm).
2. Patients under the age of 18 years.
3. Pregnant women.
4. Pacemaker dependent rhythm.
5. Ongoing angina pectoris.
6. Current NYHA Class 3-4 heart failure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HV001

Identifier Type: -

Identifier Source: org_study_id

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