NCT01626768

Brief Summary

The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation. The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
2 countries

2 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

June 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

June 19, 2012

Last Update Submit

July 16, 2013

Conditions

Tachycardia

Outcome Measures

Primary Outcomes (1)

  • In vivo lead shape

    Six Months

Study Arms (1)

Enrolled patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed at participating centers.

You may qualify if:

  • Patients greater than 18 years of age.
  • Patients able and willing to attend imaging session.
  • Patients able and willing to give informed consent.
  • Patients with an implanted device/lead(s) for a minimum of 3 months.

You may not qualify if:

  • Subjects who require a legally authorized representative to obtain consent.
  • Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Riyadh, Saudi Arabia

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 25, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

SA(1)GB(1)