NCT00888667

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

April 24, 2009

Last Update Submit

February 1, 2019

Conditions

Premature Ventricular Complexes

Keywords

ICD patients with PVCs and EGM recordings

Outcome Measures

Primary Outcomes (1)

  • % morphology match

    off line analysis

    acute

Study Arms (1)

ICD patient with frequent PVCs

Other: Pacing interventions

Interventions

Pacing interventionsOTHER

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

ICD patient with frequent PVCs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a dual chamber ICD and frequent PVCs

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

CA(1)