Optimal EGM Configuration for Morphology Discrimination (SVT Morphology)

February 1, 2019 updated by: Abbott Medical Devices

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • St Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a dual chamber ICD and frequent PVCs

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICD patient with frequent PVCs
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% morphology match
Time Frame: acute
off line analysis
acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HV001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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