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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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SelectSecure 3830 Lead Imaging

  • Clinicaltrials.gov identifier

    NCT03941275

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 7, 2019

  • Last update posted

    April 19, 2021

Study Description

Brief summary:

This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.

  • Condition or Disease:Heart Diseases
  • Intervention/Treatment: Diagnostic Test: Bi-plane fluoroscopy
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Actual Enrollment: 51 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: SelectSecure 3830 Lead Imaging
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: November 2020
  • Actual Study Completion Date: May 2021

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: Subjects undergoing bi-plane fluoroscopy
Diagnostic Test: Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead

Outcome Measures

  • Primary Outcome Measures: 1. Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead. [ Time Frame: approximately 30 minutes ]
    Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.
  • Secondary Outcome Measures: 1. Acquire accelerometer-based motion data [ Time Frame: approximately 30 minutes ]
    During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.

Criteria

Inclusion Criteria:

- Patients who are at least 18 years of age

- Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830
lead in the right atrium or right ventricle

- Patients able and willing to attend imaging session

- Patients able and willing to give informed consent

- Pacing capture threshold and pacing impedance of the lead are within normal range at
the time of enrollment

- Patient must be able to accomplish arm flexion and adduction past 90 degrees

Exclusion Criteria:

- Subjects who require a legally authorized representative to obtain consent

- Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)

- Pregnant women, or women of child bearing potential and who are not on a reliable form
of birth control

- Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less
than three months ago

Contacts and Locations

Contacts

Locations

United States, Alabama
Heart Center Research
Huntsville

United States, Iowa
Iowa Heart Center
West Des Moines

United States, Maryland
Associates in Cardiology PA
Silver Spring

United States, New Jersey
Lourdes Cardiology Services
Voorhees

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

More Information

  • Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
  • ClinicalTrials.gov Identifier: NCT03941275 History of Changes
  • Other Study ID Numbers: MDT18066
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: April 19, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Heart Diseases