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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328705
• Other study ID #: 209
• Status: Completed
• Phase: N/A
• First received: May 19, 2006
• Last updated: February 11, 2008
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular fibrillation (VF) detection time
Primary	Ventricular Capture Management accuracy