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Atrial FibrillationPhase 4IMPACTNCT00559988

Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk

A Phase 4 study testing Home Monitoring Guided OAC and Physician-Directed OAC in people with Atrial Fibrillation and Atrial Flutter, run by Biotronik, Inc. at 80 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Atrial Flutter, Stroke
What is being tested?
Home Monitoring Guided OAC and Physician-Directed OAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,718 participants
Where
80 sitesin 6 countries
Study dates
Feb 2008to Jun 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
  • Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
  • CHADS2 risk score ≥ 1
  • Able and willing to follow OAC therapy if the indication develops during the course of the trial
  • Able to utilize the HM throughout the study

Who cannot join

  • Permanent AF
  • History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
  • Currently requiring OAC therapy for any indication
  • Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
  • Known, current contraindication to use of eligible OAC
  • Long QT or Brugada syndrome as the sole indication for device implantation
  • Life expectancy less than the expected term of the study

Trial locations and contacts

80 sites in 6 countries.

80 sites in 6 countries

United States73 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Aurora, Colorado

  • Study site

    Bangor, Maine

  • Study site

    Bay City, Michigan

  • Study site

    Boston, Massachusetts

  • Study site

    Boulder, Colorado

  • Study site

    Burlington, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Cookeville, Tennessee

  • Study site

    Corpus Christi, Texas

  • Study site

    Cumberland, Maryland

  • Study site

    Davenport, Florida

  • Study site

    Daytona Beach, Florida

  • Study site

    Durham, North Carolina

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fremont, California

  • Study site

    Germantown, Tennessee

  • Study site

    Greenville, South Carolina

  • Study site

    Hammond, Louisiana

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Humble, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Kettering, Ohio

  • Study site

    Kingwood, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    Lafayette, Louisiana

  • Study site

    Lansing, Michigan

  • Study site

    Lapeer, Michigan

  • Study site

    Lewiston, Maine

  • Study site

    Lexington, Kentucky

  • Study site

    Louisville, Kentucky

  • Study site

    Maywood, Illinois

  • Study site

    Melbourne, Florida

  • Study site

    Middletown, Ohio

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Osage Beach, Missouri

  • Study site

    Owensboro, Kentucky

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Phoenixville, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rock Hill, South Carolina

  • Study site

    Saginaw, Michigan

  • Study site

    Santa Barbara, California

  • Study site

    Sarasota, Florida

  • Study site

    Scottsdale, Arizona

  • Study site

    Shawnee Mission, Kansas

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Tualatin, Oregon

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tupelo, Mississippi

  • Study site

    Valparaiso, Indiana

  • Study site

    Ventura, California

  • Study site

    Westlake, Ohio

  • Study site

    Worcester, Massachusetts

  • Study site

    Ypsilanti, Michigan

  • Study site

    Zephyrhills, Florida

Other trials in United States

Canada2 sites

  • Study site

    Montreal, Quebec

  • Study site

    Sherbrooke, Quebec

Other trials in Canada

Germany2 sites

  • Study site

    Tübingen

  • Study site

    Villingen

Other trials in Germany

Australia1 site

  • Study site

    Wahroonga

Other trials in Australia

Denmark1 site

  • Study site

    Aarhus

Other trials in Denmark

United Kingdom1 site

  • Study site

    Birmingham

Other trials in United Kingdom

About this study

Official title: The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices

The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.

Read the detailed description

Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained.

Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism.

The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke

Being tested
Home Monitoring Guided OAC, Physician-Directed OAC
Keywords
Implanted Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Home Monitoring, Oral Anticoagulation
Medical subject headings
Atrial Fibrillation, Atrial Flutter, Stroke, Embolism

What participants receive

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

  • Home Monitoring Guided OACDrug

    Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy.

    OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA

  • Physician-Directed OACDrug

    Patients will receive physician-directed anticoagulation therapy based on conventional criteria.

    OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA

Study groups in NCT00559988
Study groupRoleWhat they receive
Home Monitoring Guided OACExperimentalHome Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.
Receives: Drug: Home Monitoring Guided OAC
Physician-Directed OACActive comparatorIn Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care. Safety Net data include: * ERI/EOS * Special Implant Status * Implant in Backup Mode (ROM) * VT/ VF Detection Inactive * Emergency Pacing * 250 Ω > RV Pacing Impedance > 1500 Ω * Symptomatic VT/VF therapies including both ATP and shock * VT/VF storm * HM transmission failure >3 days
Receives: Drug: Physician-Directed OAC

What is being measured

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

  1. Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed

    The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.

    Measured: From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years

Secondary outcomes (8)

  1. Rates of All-cause Mortality

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  2. Rate of Ischemic and Hemorrhagic Stroke

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  3. Rate of Fatal or Disabling and Non-disabling Stroke

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  4. Rate of Major Bleeding Events

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  5. Mean Atrial Fibrillation/Atrial Flutter Burden

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  6. Rate of Cardioembolic and Non-cardioembolic Stroke

    Measured: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

  7. Change in Quality of Life Score

    Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.

    Measured: 1 year

  8. Mean Ventricular Heart Rate Reduction

    Measured: 1 year

Timeline

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

  1. First posted19 Nov 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionJun 2013
  4. Study completionJun 2013

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
2,718 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559988
Sponsor's protocol ID
IMPACT
Acronym
IMPACT
Status last verified
Nov 2017
First submitted
15 Nov 2007
Last updated
5 Dec 2017
Data monitoring committee
Yes

Publications

  • Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J. 2015 Jul 7;36(26):1660-8. doi: 10.1093/eurheartj/ehv115. Epub 2015 Apr 23.

    PubMed 25908774

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Home Monitoring Guided OAC and Physician-Directed OAC in people with Atrial Fibrillation and Atrial Flutter, run by Biotronik, Inc. at 80 sites in 6 countries.

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 5 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: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, Germany, Australia, Denmark and 1 more country. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed (time frame: From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years). 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 NCT00559988, which also lists 1 linked publication.

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 5 Dec 2017.

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IMPACT Clinical Trial NCT00559988 | AzTrials