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CompletedNCT00328705Updated Feb 13, 2008

D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

An interventional study of Implantable Cardioverter Defibrillator in Heart Diseases, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-13.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Read the detailed description

The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

02

Conditions studied

  • Heart Diseases

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Keywords

  • Sensing
  • Capture Management
  • Heart Failure
  • ICD Indication
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 65 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  • Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.

Exclusion criteria

Exclusion Criteria:

  • Patients who have 3rd degree heart block, as assessed by the investigator
  • Patients who have a mechanical tricuspid heart valve
  • Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Interventions

  • DeviceImplantable Cardioverter Defibrillator
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What researchers measure

Primary outcomes

  1. Ventricular fibrillation (VF) detection time

  2. Ventricular Capture Management accuracy

07

Study locations

5 sites
  • Tampa, Florida, United States
  • Coon Rapids, Minnesota, United States
  • Rochester, Minnesota, United States
  • St. Paul, Minnesota, United States
  • Charlotte, North Carolina, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00328705
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
First posted
May 22, 2006
Start date
May 2006
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Feb 13, 2008

Study contacts

Cole Hannon
study director · Medtronic CRDM

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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