Tachycardia
Conditions
Brief summary
RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.
Detailed description
RIGHT will compare the incidence of Ventricular Tachycardia/Fibrillation (VT/VF) therapies delivered for Supraventricular Tachycardia (SVT) episodes using VITALITY 2 devices with Rhythm ID™ to that of ICDs employing other rhythm discrimination algorithms. Appropriateness of therapies will be assessed after independent adjudication of all VT/VF events leading to therapy. Comparisons will be made between device manufacturers across patient populations receiving either a dual- or single-chamber device.
Interventions
DEVICEVITALITY 2 Implantable Cardioverter Defibrillator
VITALITY 2 ICD
DEVICEMedtronic Implantable Cardioverter Defibrillator
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet current indications for an ICD * Patients who sign and date a Patient Informed Consent form prior to the implant visit * Patients who remain in the clinical care of the enrolling physician in approved centers * Patients who are able to tolerate ICD programming as specifically prescribed in the study protocol
Exclusion criteria
* Patients who are in third degree heart block * Patients whose life expectancy is less than 12 months * Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study * Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study * Patients who are younger than 18 years of age * Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study * Patients who are pregnant or plan to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | From date of pre-discharge until a minimum of 12 months follow-up until study closure | An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery. |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs) | Time of event |
| Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs) | Time of event |
| Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode | Time of event |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VITALITY 2 VITALITY 2 ICD | 985 |
| Medtronic Family Selected Medtronic family devices | 977 |
| Total | 1,962 |
Baseline characteristics
| Characteristic | VITALITY 2 | Medtronic Family | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 496 Participants | 495 Participants | 991 Participants |
| Age, Categorical Between 18 and 65 years | 489 Participants | 482 Participants | 971 Participants |
| Age Continuous | 64.3 years STANDARD_DEVIATION 12.4 | 64.4 years STANDARD_DEVIATION 12 | 64.3 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment Canada | 5 participants | 5 participants | 10 participants |
| Region of Enrollment Europe | 65 participants | 63 participants | 128 participants |
| Region of Enrollment United States | 915 participants | 909 participants | 1824 participants |
| Sex: Female, Male Female | 223 Participants | 197 Participants | 420 Participants |
| Sex: Female, Male Male | 762 Participants | 780 Participants | 1542 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 535 / 985 | 508 / 977 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
Time frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VITALITY 2 | Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | 246 Participants |
| Medtronic Family | Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | 187 Participants |
p-value: 0.00395% CI: [1.11, 1.62]Regression, Cox
Secondary
Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
Time frame: Time of event
Secondary
Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
Time frame: Time of event
Secondary
Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
Time frame: Time of event