An observational study in Ventricular Tachycardia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational
The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.
The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
Subject is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:
Exclusion Criteria:
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
Other: TPD RAMWare
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
Time frame: 1 year
| Milestone | TPD RAMWare Download |
|---|---|
| Started | 138 |
| Completed | 76 |
| Not completed | 62 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Protocol violation | 10 |
| Withdrew: Sponsor request/study termination | 29 |
| Withdrew: Study product no longer in use | 1 |
| Withdrew: Technical problems | 1 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Physician decision | 2 |
| Withdrew: Upgrade to cardiac resynchronization therapy-defibrillator/stage iv cancer | 3 |
| Withdrew: Death | 4 |
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
| Participants | TPD RAMWare Download |
|---|---|
| Participants with device detected ventricular tachycardia/ventricular fibrillation episodes | 31 |
| Participants with no device detected ventricular tachycardia/ventricular fibrillation episode | 97 |
Collected over 1 year (12 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TPD RAMWare Download | 4/128 (3.1%) | 0/128 (0%) | 0/128 (0%) |
Total number of all participants for whom baseline characteristics were measured and received the Ramware injection. 138 participants were assessed for eligibility but only 128 had baseline characteristics measured and received the Ramware injected. 10 participants did not receive Ramware injection and undergo baseline characteristic measurements due to 8 experiencing screen failures, 1 experiencing noncompliance, and 1 being removed due to physician decision.
| Age, Continuous(years) | TPD RAMWare Injected |
|---|---|
| Mean | 62 ± 13.5 |
| Sex: Female, Male(Participants) | TPD RAMWare Injected |
|---|---|
| Female | 24 |
| Male | 104 |
| Ethnicity (NIH/OMB)(Participants) | TPD RAMWare Injected |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 126 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | TPD RAMWare Injected |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 29 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 81 |
| More than one race | 0 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(participants) | TPD RAMWare Injected |
|---|---|
| Hong Kong | 28 |
| United States | 100 |
| Body Mass Index(kg/m^2) | TPD RAMWare Injected |
|---|---|
| Mean | 29.8 ± 6.9 |
| Weight(kg) | TPD RAMWare Injected |
|---|---|
| Mean | 90.1 ± 22.5 |
| Height(cm) | TPD RAMWare Injected |
|---|---|
| Mean | 173.8 ± 10.0 |
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Medtronic Cardiac Rhythm and Heart Failure