INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs (NCT00148967) | Clinical Trial Compass
CompletedPhase 4
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
1,535 participantsStarted 2003-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.