INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

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.

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.

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