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DF4 Connector System Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01638897
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic

Tracking Information
First Submitted Date July 3, 2012
First Posted Date July 12, 2012
Last Update Posted Date March 20, 2019
Study Start Date January 2012
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2012)
DF4 Lead Related Complication Rate [ Time Frame: Up to 5 Years ]
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01638897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 9, 2012)
  • Types of DF4 lead related events [ Time Frame: Up to 5 years ]
    Number of DF4 lead related events grouped by type
  • Bipolar pacing impedance (ohms) [ Time Frame: 5 years ]
    Summary statistics at 5 years post-implant will be reported.
  • High voltage impedance (ohms) [ Time Frame: 5 years ]
    Summary statistics at 5 years post-implant will be reported
  • Pacing threshold (volts) [ Time Frame: 5 years ]
    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 ]
    The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DF4 Connector System Post-Approval Study
Official Title DF4 Connector System Post-Approval Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Sudden Cardiac Death
  • Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2012)
1778
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   France,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number NCT01638897
Other Study ID Numbers DF4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic
Study Sponsor Medtronic
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic
Verification Date March 2019