Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
Conditions
Keywords
Cardiac Pacing, Implantable Cardioverter Defibrillator, pacemaker, Sinus Bradycardia
Brief summary
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.
Detailed description
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Interventions
DEVICEDevice
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects who meet the following inclusion criteria and do not meet any of the following
Exclusion criteria
are eligible for enrollment. Inclusion Criteria: • Subject 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 must also apply: * Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application * Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lead related complications for each lead model. | Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive). | All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable. |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTMedtronic CRM Clinical Trials
STUDY_CHAIRProduct Performance Report Study Leader
Medtronic
Outcome results
None listed