NCT00328705

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

May 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 13, 2008

Status Verified

February 1, 2008

Enrollment Period

8 months

First QC Date

May 19, 2006

Last Update Submit

February 11, 2008

Conditions

Heart Diseases

Keywords

SensingCapture ManagementHeart FailureICD Indication

Outcome Measures

Primary Outcomes (2)

  • Ventricular fibrillation (VF) detection time

  • Ventricular Capture Management accuracy

Interventions

Implantable Cardioverter DefibrillatorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Coon Rapids, Minnesota, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

MeSH Terms

Conditions

Heart DiseasesHeart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Cole Hannon

    Medtronic CRDM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

May 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 13, 2008

Record last verified: 2008-02

Locations

US(5)