The REACT-ICD Trial

NCT02439424 | Unknown Phase 1

• 1 other identifier: HHC-2015-0024
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Tachyarrhythmia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• atrial fibrillation burden

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

  6 months

Secondary Outcomes (5)

• Persistent/permanent atrial fibrillation

  6 months

• cardioversion

  6 months

• cardiovascular hospitalization

  6 months

• percentage of ventricular pacing

  6 months

• Ventricular tachycardia/Ventricular fibribilation ICD therapies

  6 months

Study Arms (1)

Reactive ATP

EXPERIMENTAL

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

Device: Reactive ATP

Interventions

Reactive ATP DEVICE

Reactive ATP turned to "on"

Reactive ATP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (5)

• 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.

  PMID: 10694527 BACKGROUND

• 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.

  PMID: 22588842 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.

  PMID: 14715182 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.

  PMID: 16050828 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.

  PMID: 11499724 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Zweibel, MD

  Hartford HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 8, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

US (1)