Arrhythmia, Heart Failure
Conditions
Keywords
Epicardial, Pacing Lead
Brief summary
The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.
Detailed description
The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board * Availability of implant, follow-up, and product-related event data * Implanted with a Model 4968 Capsure Epi Lead
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 4968 Post-approval study 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 |
|---|---|---|
| Survival Probability of the Model 4968 Lead Based on Lead-related Complications | The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety. | The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability. |
Countries
Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia and Montenegro, Spain, Sweden, Switzerland, United States
Participant flow
Recruitment details
All enrolled patients with at least 1 Model 4968 lead implanted
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Patients All patients who were enrolled and implanted with a Model 4968 Lead | 370 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 22 leads were excluded from analysis | 21 |
Baseline characteristics
| Characteristic | All Enrolled Patients |
|---|---|
| Age, Customized 0 - 12 Years | 155 participants |
| Age, Customized 13 - 19 Years | 49 participants |
| Age, Customized 20 + Years | 145 participants |
| Age, Customized Unknown | 21 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants |
| Race/Ethnicity, Customized Not Reportable per Local Laws/Regulations | 2 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized Race/Ethnicity not collected | 345 participants |
| Race/Ethnicity, Customized White | 16 participants |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 232 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 349 |
| serious Total, serious adverse events | 30 / 349 |
Outcome results
Primary
Survival Probability of the Model 4968 Lead Based on Lead-related Complications
The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.
Time frame: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.
Population: 22 Model 4968s (in 21 participants) was not available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4968 Lead Survival Probability | Survival Probability of the Model 4968 Lead Based on Lead-related Complications | 92.3 percentage of Model 4968 Leads |