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The REACT-ICD Trial (REACT-ICD)

Primary Purpose

Atrial Tachyarrhythmia, Atrial Fibrillation

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Reactive ATP
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Tachyarrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male and female patients
  • ≥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:

  • Persistent or permanent AT/AF (AF burden >95%)
  • 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

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reactive ATP

Arm Description

all enrolled subjects will have the Reactive ATP feature in their ICD turned "on"

Outcomes

Primary Outcome Measures

atrial fibrillation burden
% of time in atrial fibrillation = time in atrial fibrillation (over 6 months of study) / 6 months

Secondary Outcome Measures

Persistent/permanent atrial fibrillation
number/percentage of patients in persistent (7 days) or permanent atrial fibrillation
cardioversion
number/percentage of patients who underwent cardioversion
cardiovascular hospitalization
number/percentage of patients who were hospitalized for cardiac-related issues
percentage of ventricular pacing
percentage of ventricular beats that are paced by the ICD
Ventricular tachycardia/Ventricular fibribilation ICD therapies
number of appropriate or inappropriate therapies (ATP [antitachycardiac pacing] or shock)

Full Information

First Posted
April 21, 2015
Last Updated
December 21, 2016
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02439424
Brief Title
The REACT-ICD Trial
Acronym
REACT-ICD
Official Title
The Effect of Reactive ATP™ on the Burden of Atrial Fibrillation in ICD Patients: The REACT-ICD Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 ATP™) 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 ATP™ 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.
Detailed Description
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Tachyarrhythmia, Atrial Fibrillation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reactive ATP
Arm Type
Experimental
Arm Description
all enrolled subjects will have the Reactive ATP feature in their ICD turned "on"
Intervention Type
Device
Intervention Name(s)
Reactive ATP
Intervention Description
Reactive ATP turned to "on"
Primary Outcome Measure Information:
Title
atrial fibrillation burden
Description
% of time in atrial fibrillation = time in atrial fibrillation (over 6 months of study) / 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Persistent/permanent atrial fibrillation
Description
number/percentage of patients in persistent (7 days) or permanent atrial fibrillation
Time Frame
6 months
Title
cardioversion
Description
number/percentage of patients who underwent cardioversion
Time Frame
6 months
Title
cardiovascular hospitalization
Description
number/percentage of patients who were hospitalized for cardiac-related issues
Time Frame
6 months
Title
percentage of ventricular pacing
Description
percentage of ventricular beats that are paced by the ICD
Time Frame
6 months
Title
Ventricular tachycardia/Ventricular fibribilation ICD therapies
Description
number of appropriate or inappropriate therapies (ATP [antitachycardiac pacing] or shock)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male and female patients ≥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: Persistent or permanent AT/AF (AF burden >95%) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Zweibel, MD
Organizational Affiliation
Hartford HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10694527
Citation
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.
Results Reference
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PubMed Identifier
22588842
Citation
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.
Results Reference
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PubMed Identifier
14715182
Citation
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.
Results Reference
background
PubMed Identifier
16050828
Citation
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.
Results Reference
background
PubMed Identifier
11499724
Citation
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.
Results Reference
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The REACT-ICD Trial

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