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Recent advancements with implantable cardiac device technology include extensive diagnostic and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias (ATA). Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm (Reactive ATPâ„¢) in conjunction with managed ventricular pacing (MVP) recently has been shown to reduce progression to permanent atrial fibrillation (AF) in pacemaker patients with intact atriovenous (AV) conduction and a history of ATA. Whether the use of Reactive ATPâ„¢ for reducing AF burden extends to patients with an implantable cardioverter defibrillator (ICD), who typically have structural heart disease and heart hailure (HF), is unknown.
Atrial tachyarrhythmias (ATA) and heart failure (HF), which are well-recognized causes of morbidity and mortality, are growing and concerning issues in our patient population. In patients implanted with a dual-chamber implantable cardioverter defibrillator (ICD), progression of paroxysmal to persistent or permanent atrial fibrillation (AF) has been documented. Because of the untoward consequences of AF, such as development/worsening of HF or thromboembolic events (stroke and myocardial infarction [MI]), prevention of permanent AF has the potential to improve quality of life, reduce hospitalizations, and decrease the complications associated with AF.
Recent advancements with implantable cardiac device technology include extensive diagnostic and therapeutic algorithms for prevention as well as termination of ATA. Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm (Reactive ATPâ„¢) in conjunction with managed ventricular pacing (MVP) recently has been shown to reduce progression to permanent AF in pacemaker patients with intact atriovenous (AV) conduction and a history of ATA. Results of that study suggested that Reactive ATPâ„¢ specifically was responsible for this effect. Whether the use of Reactive ATPâ„¢ for reducing AF burden extends to patients with an implantable cardioverter defibrillator (ICD), who typically have structural heart disease and HF, is unknown.
The aim of this study is to evaluate the effectiveness of atrial antitachycardia pacing (Reactive ATP) in patients implanted with either a dual-chamber or cardiac resynchronization therapy (CRT) ICD who have a history of ATA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reactive ATP | Experimental | all enrolled subjects will have the Reactive ATP feature in their ICD turned "on" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reactive ATP | Device | Reactive ATP turned to "on" |
|
| Measure | Description | Time Frame |
|---|---|---|
| atrial fibrillation burden | % of time in atrial fibrillation = time in atrial fibrillation (over 6 months of study) / 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent/permanent atrial fibrillation | number/percentage of patients in persistent (7 days) or permanent atrial fibrillation | 6 months |
| cardioversion | number/percentage of patients who underwent cardioversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Zweibel, MD | Hartford HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10694527 | Background | Swerdlow CD, Schsls W, Dijkman B, Jung W, Sheth NV, Olson WH, Gunderson BD. Detection of atrial fibrillation and flutter by a dual-chamber implantable cardioverter-defibrillator. For the Worldwide Jewel AF Investigators. Circulation. 2000 Feb 29;101(8):878-85. doi: 10.1161/01.cir.101.8.878. | |
| 22588842 | Background |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 6 months |
| cardiovascular hospitalization | number/percentage of patients who were hospitalized for cardiac-related issues | 6 months |
| percentage of ventricular pacing | percentage of ventricular beats that are paced by the ICD | 6 months |
| Ventricular tachycardia/Ventricular fibribilation ICD therapies | number of appropriate or inappropriate therapies (ATP [antitachycardiac pacing] or shock) | 6 months |
| Lampe B, Hammerstingl C, Schwab JO, Mellert F, Stoffel-Wagner B, Grigull A, Fimmers R, Maisch B, Nickenig G, Lewalter T, Yang A. Adverse effects of permanent atrial fibrillation on heart failure in patients with preserved left ventricular function and chronic right apical pacing for complete heart block. Clin Res Cardiol. 2012 Oct;101(10):829-36. doi: 10.1007/s00392-012-0468-7. Epub 2012 May 16. |
| 14715182 | Background | Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027. |
| 16050828 | Background | Boriani G, Padeletti L, Santini M, Gulizia M, Capucci A, Botto G, Ricci R, Molon G, Accogli M, Vicentini A, Biffi M, Vimercati M, Grammatico A. Predictors of atrial antitachycardia pacing efficacy in patients affected by brady-tachy form of sick sinus syndrome and implanted with a DDDRP device. J Cardiovasc Electrophysiol. 2005 Jul;16(7):714-23. doi: 10.1111/j.1540-8167.2005.40716.x. |
| 11499724 | Background | Israel CW, Ehrlich JR, Gronefeld G, Klesius A, Lawo T, Lemke B, Hohnloser SH. Prevalence, characteristics and clinical implications of regular atrial tachyarrhythmias in patients with atrial fibrillation: insights from a study using a new implantable device. J Am Coll Cardiol. 2001 Aug;38(2):355-63. doi: 10.1016/s0735-1097(01)01351-1. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |