Clinical trial NCT00148967: INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
Official title: Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia
Keywords: right ventricular pacing
implantable cardioverter defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 1535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.
Secondary outcomes:
measure: The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:
measure: The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Brian Olshansky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utah Heart Clinic
name: John Day, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan RM, Russo AM, Berg KC, Stolen KQ, Seth M, Perschbacher D, Day JD, Olshansky B. Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial. Heart Rhythm. 2012 Mar;9(3):351-8. doi: 10.1016/j.hrthm.2011.10.018. Epub 2011 Oct 19.
citation: Ahmadi-Kashani M, Kessler DJ, Day J, Bunch TJ, Stolen KQ, Brown S, Sbaity S, Olshansky B; INTRINSIC RV Study Investigators. Heart rate predicts outcomes in an implantable cardioverter-defibrillator population. Circulation. 2009 Nov 24;120(21):2040-5. doi: 10.1161/CIRCULATIONAHA.108.847608. Epub 2009 Nov 9.
citation: Bunch TJ, Day JD, Olshansky B, Stolen KQ, Mullin CM; INTRINSIC RV Study Investigators. Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality. Heart Rhythm. 2009 Jan;6(1):2-8. doi: 10.1016/j.hrthm.2008.09.025. Epub 2008 Sep 27.