INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
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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.
Condition or disease
Device: Implantable Cardioverter Defibrillator
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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
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