INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
NCT ID: NCT00148967
Last Updated: 2006-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1535 participants
INTERVENTIONAL
2003-07-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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Implantable Cardioverter Defibrillator
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Principal Investigators
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Brian Olshansky, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
John Day, MD
Role: PRINCIPAL_INVESTIGATOR
Utah Heart Clinic
References
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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.
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.
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.
Other Identifiers
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CR-CA-051403-T
Identifier Type: -
Identifier Source: org_study_id