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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations. |
| Measure | Description | Time Frame |
|---|---|---|
| The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI: | ||
| The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Olshansky, MD | University of Iowa | Principal Investigator |
| John Day, MD | Utah Heart Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22016074 | Derived | 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. | |
| 19901194 | Derived |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 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. |
| 18996055 | Derived | 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |