DF4 Connector System Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01638897
First received: July 3, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector systems. This study is conducted within Medtronic's post-market surveillance platform.


Condition
Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: DF4 Connector System Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • DF4 Lead Related Complication Rate [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead


Secondary Outcome Measures:
  • Types of DF4 lead related events [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Number of DF4 lead related events grouped by type

  • Bipolar pacing impedance (ohms) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Summary statistics at 5 years post-implant will be reported.

  • High voltage impedance (ohms) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Summary statistics at 5 years post-implant will be reported

  • Pacing threshold (volts) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported.

  • Sensing amplitude (millivolts) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.


Estimated Enrollment: 1778
Study Start Date: January 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients intended to be implanted or are within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application

Exclusion Criteria:

  • Subject who is, or will be inaccessible for follow-up at a study site
  • Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
  • Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638897

  Show 111 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01638897     History of Changes
Other Study ID Numbers: DF4
Study First Received: July 3, 2012
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
ICD
CRTD
DF4

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on September 14, 2014