AzTrials
AzTrials

BradycardiaNCT00294645

PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

A study testing Transtelephonic monitoring (TTM) and Medtronic CareLink® Network in people with Bradycardia and Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who are followed via routine office… Read more about this study

Who is it for?
Any age
Conditions the study is for
Bradycardia, Arrhythmia
What is being tested?
Transtelephonic monitoring (TTM) and Medtronic CareLink® Network
Could I receive a placebo?
No, everyone receives an active treatment
How many people
980 participants
Where
45 sitesUnited States
Study dates
Apr 2004to Apr 2008
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient has been previously implanted with a dual-chamber or single-chamber EnPulse®, Kappa 900®, or Adapta® device
  • Patient agrees to complete all required follow-up transmissions and in-office visits
  • Patient is capable of operating the TTM monitor and Medtronic CareLink monitor

Who cannot join

  • Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Bangor, Maine

  • Study site

    Bend, Oregon

  • Study site

    Burlington, Massachusetts

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Des Moines, Iowa

  • Study site

    Glen Burnie, Maryland

  • Study site

    Great Falls, Montana

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Houston, Texas

  • Study site

    Jackson, Mississippi

  • Study site

    Kansas City, Missouri

  • Study site

    Lafayette, Louisiana

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Little Rock, Arkansas

  • Study site

    Marion, Ohio

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    Ocean City, New Jersey

  • Study site

    Omaha, Nebraska

  • Study site

    Ormond Beach, Florida

  • Study site

    Paterson, New Jersey

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Raleigh, North Carolina

  • Study site

    Reno, Nevada

  • Study site

    Safety Harbor, Florida

  • Study site

    Scottsdale, Arizona

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Tacoma, Washington

  • Study site

    Takoma Park, Maryland

  • Study site

    Temple, Texas

  • Study site

    Towaco, New Jersey

  • Study site

    Tulsa, Oklahoma

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    Wynnewood, Pennsylvania

Other trials in United States

About this study

Official title: Pacemaker Remote Follow-up Evaluation and Review

The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who are followed via routine office visits augmented by transtelephonic monitoring (TTM)(Control arm).

Read the detailed description

The Clinically Actionable Events (CAE) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The defined events are:

  1. Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of AT/AF per day
  2. Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation
  3. A sensed ventricular response of greater than 100 beats per minute (BPM) during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation
  4. Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats
  5. New onset of AT/AF among patients with no history of AT/AF
  6. Loss of atrial capture
  7. Loss of ventricular capture
  8. Increase in atrial pacing voltage threshold greater than 1 volt (V)
  9. Increase in ventricular pacing voltage threshold greater than 1 volt (V)
  10. \& 11. Significant change in atrial or ventricular lead impedance, defined as any of the following:
  11. Less than 200 or greater than 2000 ohms (Ω)
  12. Unstable lead impedance deemed to be clinically actionable
  13. Greater than 50 percent change in lead impedance since last interrogation
  14. Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators
Being tested
Transtelephonic monitoring (TTM), Medtronic CareLink® Network
Keywords
Remote Follow Up, Diagnostic, Bradycardia
Medical subject headings
Bradycardia, Arrhythmias, Cardiac, Disease

What participants receive

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

  • Transtelephonic monitoring (TTM)Other

    TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.

  • Medtronic CareLink® NetworkOther

    Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.

Study groups in NCT00294645
Study groupRoleWhat they receive
ControlActive comparatorTranstelephonic monitoring at 2 month intervals
Receives: Other: Transtelephonic monitoring (TTM)
RemoteActive comparatorMedtronic CareLink® Network remote pacemaker interrogation at 3 month intervals
Receives: Other: Medtronic CareLink® Network

What is being measured

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

  1. Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months

    Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.

    Measured: One year post-enrollment

Secondary outcomes (13)

  1. Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events

    Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other

    Measured: One year post-enrollment

  2. Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months

    Compare time to first diagnosis in Remote and Control arms

    Measured: One year post-enrollment

  3. Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months

    Compare time to diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  4. Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months

    Compare time to diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  5. Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  6. Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  7. Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  8. Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months

    Compare time to first diagnosis in Remote and Control arms

    Measured: One year post-enrollment

  9. Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months

    Compare time to first diagnosis in Remote and Control arms

    Measured: One year post-enrollment

  10. Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  11. Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  12. Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

  13. Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months

    Compare time to first diagnosis in Control and Remote arms

    Measured: One year post-enrollment

Timeline

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

  1. First posted22 Feb 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2008
  4. Study completionApr 2008

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
980 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00294645
Sponsor's protocol ID
701
Status last verified
Oct 2010
First submitted
20 Feb 2006
Last updated
19 Oct 2010
Data monitoring committee
No

Publications

  • Chen J, Wilkoff BL, Choucair W, Cohen TJ, Crossley GH, Johnson WB, Mongeon LR, Serwer GA, Sherfesee L. Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients. Trials. 2008 Apr 3;9:18. doi: 10.1186/1745-6215-9-18.

    PubMed 18387185

  • Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL; PREFER Study Investigators. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol. 2009 Nov 24;54(22):2012-9. doi: 10.1016/j.jacc.2009.10.001.

    PubMed 19926006

Questions about this trial

What is this clinical trial studying?

A study testing Transtelephonic monitoring (TTM) and Medtronic CareLink® Network in people with Bradycardia and Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 45 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2010). 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?

Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months (time frame: One year post-enrollment). 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 NCT00294645, which also lists 2 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 19 Oct 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in