Tachycardia
Conditions
Keywords
right ventricular pacing, implantable cardioverter defibrillator
Brief summary
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
Detailed description
The purpose of study is to assess whether AVSH will provide benefits of a dual-chamber ICD without the deleterious effects of unnecessary RV pacing. This study will aim to demonstrate that DDDR-AVSH is equal to VVI with respect to mortality and HF hospitalizations.
Interventions
DEVICEImplantable Cardioverter Defibrillator
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients who meet VITALITY™AVT® ICD indications * Patients who sign and date a Patient Informed Consent prior to device implant * Patients who remain in the clinical care of the enrolling physician
Exclusion criteria
* Patients with current indication for CRT-D * Patients who previously had a pacemaker, ICD or CRT-D * Patients with chronic AF * Patients whose life expectancy is \<12 months due to other medical conditions * Patients who are expected to receive a heart transplant during the duration of the study * Patients with epicardial pacing leads * Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed * Patients with or who are likely to receive a tricuspid or other valve prosthesis * Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study * Patients who are younger than 18 years of age * Patients who are pregnant * Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI: | — |
| The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life | — |
Outcome results
None listed