Ventricular Tachycardia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERTPD RAMWare
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: * Secondary Prevention or, * Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF * Subject is ≥ 18 years old * Subject has previously documented history of VT/VF * Subject must be willing and able to use Medtronic CareLink network monitoring system * Subject provides signed and dated authorization and/or consent per institution and local requirements * Subject is willing and able to comply with the protocol
Exclusion criteria
* Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF * Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager * Subject has chronic AF * Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death (Channelopathies): Long QT and Brugada Syndromes * Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink * Subject has active electronic medical device other than an ICD * Subject requires more than 25% atrial or ventricular pacing * Subject has medical conditions that would limit study participation (per investigator judgment) * Subject has projected life expectancy of less than 1 year * Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study) * Subject meets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes | 1 year | This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation. |
Countries
Hong Kong, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TPD RAMWare Injected Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare: TPD RAMWare injected into enrolled subject's device. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Sponsor request/Study termination | 29 |
| Overall Study | Study product no longer in use | 1 |
| Overall Study | Technical problems | 1 |
| Overall Study | upgrade to Cardiac Resynchronization Therapy-Defibrillator/stage IV cancer | 3 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | TPD RAMWare Injected |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 13.5 |
| Body Mass Index | 29.8 kg/m^2 STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 173.8 cm STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment Hong Kong | 28 participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 104 Participants |
| Weight | 90.1 kg STANDARD_DEVIATION 22.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 128 |
| other Total, other adverse events | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TPD RAMWare Download | Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes | Participants with device detected ventricular tachycardia/ventricular fibrillation episodes | 31 Participants |
| TPD RAMWare Download | Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes | Participants with no device detected ventricular tachycardia/ventricular fibrillation episode | 97 Participants |