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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UNKNOWN
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2015-12-31
2017-03-31
Brief Summary
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Detailed Description
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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 ATP™) 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 ATP™ specifically was responsible for this effect. Whether the use of Reactive ATP™ 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Reactive ATP
all enrolled subjects will have the Reactive ATP feature in their ICD turned "on"
Reactive ATP
Reactive ATP turned to "on"
Interventions
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Reactive ATP
Reactive ATP turned to "on"
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old (no upper age limit)
* previously implanted with a Medtronic dual-chamber or CRT ICD with capability of atrial antitachycardia pacing; specifically, Reactive ATP™ at least 9 months previously (six months data collection and implant occurring at least 3 months previously to allow healing and establishment of stable sensing)
* measured P wave in sinus rhythm of at least 0.8 mV
* \>=6 months AT/AF burden data available, either from CareLink® or in-office interrogation
* \>=1.0% AT/AF burden (hours in atrial fibrillation/total hours monitored) in the last 6 months
* No change in antiarrhythmic drug therapy (Vaughan-Williams class I or III) in the last 6 months
Exclusion Criteria
* Cardioversion for atrial fibrillation or atrial flutter within the last 6 months, either intentional or as a result of a tachyarrhythmia therapy
* Ablation for atrial fibrillation or atrial flutter within the last 9 months (6 months data collection following a 3 month blanking period post procedure)
* Reactive ATP™ previously programmed on
* Measured P waves in sinus rhythm consistently \<0.8 mV on repeat measurements.
* Unresolved artifactual AT/AF detection due to far-field R wave or other oversensing
* Expected generator change or other device surgery within six months
18 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Principal Investigators
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Steven Zweibel, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford HealthCare
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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HHC-2015-0024
Identifier Type: -
Identifier Source: org_study_id