Arrhythmia, Bradycardia, Heart Failure, Pacing
Conditions
Keywords
Epicardial, Pacing Lead
Brief summary
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
Detailed description
As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB AND one of the following (A, B, or C) must also apply: A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application. B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom: * product is market-released * complete implant and follow-up data, including product-related adverse events, are available * subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead. Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.
Exclusion criteria
* Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant * Subjects who are, or will be inaccessible for follow-up at a SLS center * Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded * Subjects with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Model 4965 Complication Free Rate | 1 year | A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed. |
Countries
Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia, Spain, Sweden, Switzerland, United States
Participant flow
Recruitment details
The study utilized centers that had implanted model 4965 leads in adult subjects to obtain information regarding safety, lead events, and lead survival.
Participants by arm
| Arm | Count |
|---|---|
| Medtronic 4965 Subjects Single arm registry of Model 4965 implanted patients | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | Medtronic 4965 Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 41 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 61.8 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Germany | 1 participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 73 |
| serious Total, serious adverse events | 2 / 73 |
Outcome results
Primary
Model 4965 Complication Free Rate
A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
Time frame: 1 year
Population: Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic 4965 Epicardial Lead | Model 4965 Complication Free Rate | 98.8 Model 4965 complication free rate |