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Atrial TachyarrhythmiaPhase 1/2REACT-ICDNCT02439424

The REACT-ICD Trial

A Phase 1/2 study testing Reactive ATP in people with Atrial Tachyarrhythmia and Atrial Fibrillation, run by Hartford Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Recent advancements with implantable cardiac device technology include extensive diagnostic and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias (ATA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Tachyarrhythmia, Atrial Fibrillation
What is being tested?
Reactive ATP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Dec 2015to Mar 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hartford Hospital

    Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: The Effect of Reactive ATP™ on the Burden of Atrial Fibrillation in ICD Patients: The REACT-ICD Trial

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.

Read the 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.

Being tested
Reactive ATP
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reactive ATPDevice

    Reactive ATP turned to "on"

Study groups in NCT02439424
Study groupRoleWhat they receive
Reactive ATPExperimentalall enrolled subjects will have the Reactive ATP feature in their ICD turned "on"
Receives: Device: Reactive ATP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. atrial fibrillation burden

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

    Measured: 6 months

Secondary outcomes (5)

  1. Persistent/permanent atrial fibrillation

    number/percentage of patients in persistent (7 days) or permanent atrial fibrillation

    Measured: 6 months

  2. cardioversion

    number/percentage of patients who underwent cardioversion

    Measured: 6 months

  3. cardiovascular hospitalization

    number/percentage of patients who were hospitalized for cardiac-related issues

    Measured: 6 months

  4. percentage of ventricular pacing

    percentage of ventricular beats that are paced by the ICD

    Measured: 6 months

  5. Ventricular tachycardia/Ventricular fibribilation ICD therapies

    number of appropriate or inappropriate therapies (ATP [antitachycardiac pacing] or shock)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439424
Sponsor's protocol ID
HHC-2015-0024
Acronym
REACT-ICD
Status last verified
Dec 2016
First submitted
21 Apr 2015
Last updated
23 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10694527

  • 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.

    PubMed 22588842

  • 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.

    PubMed 14715182

  • 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.

    PubMed 16050828

  • 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.

    PubMed 11499724

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Reactive ATP in people with Atrial Tachyarrhythmia and Atrial Fibrillation, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

atrial fibrillation burden (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02439424, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.

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