ArrhythmiaNCT00627328
The Atrial High Rate Episodes in Pacemaker Patients
An observational study of Arrhythmia and Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 42 sites in 3 countries.
Trial summary
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arrhythmia, Atrial Fibrillation, Atrioventricular Block
- How many people
- 427 participants
- Where
- 42 sitesin 3 countries
- Study dates
- Jul 2000to Sep 2004
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective study with patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications.
Who may be able to join
- Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications
- No previous history of pacemaker implantation
- Patients 50 years of age or older
Who cannot join
- Patients with a history of atrial tachyarrhythmias (primary arm of study)
- Patients with medical conditions that would limit study participation
- Patients inaccessible for follow-up at the study center
- Patients incapable of providing Informed Consent
- Patients with NYHA classification of IV
- Patients with a history of neurocardiogenic syncope, long QT syndrome, or Hypertrophic Obstructive Cardiomyopathy (HOCM)
- Patients taking Sotalol or Amiodorone
- Patients with a history of a prior ICD or pacemaker implantation.
Trial locations and contacts
42 sites in 3 countries.
42 sites in 3 countries
United States37 sites
Study site
Bethlehem, Pennsylvania
Study site
Charlotte, North Carolina
Study site
Chattanooga, Tennessee
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
Falls Church, Virginia
Study site
Flushing, New York
Study site
Fresno, California
Study site
Gastonia, North Carolina
Study site
Glendale, California
Study site
Greenville, North Carolina
Study site
Hammond, Indiana
Study site
Hobart, Indiana
Study site
Hot Springs, Arkansas
Study site
Little Rock, Arkansas
Study site
Livingston, New Jersey
Study site
Louisville, Kentucky
Study site
Marrero, Louisiana
Study site
Mechanicsburg, Pennsylvania
Study site
Milwaukee, Wisconsin
Study site
Munster, Indiana
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Patterson, New Jersey
Study site
Providence, Rhode Island
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Saint Cloud, Minnesota
Study site
Salisbury, Maryland
Study site
San Diego, California
Study site
Scranton, Pennsylvania
Study site
Shreveport, Louisiana
Study site
Syracuse, New York
Study site
The Bronx, New York
Study site
West Roxbury, Massachusetts
Study site
Willimington, North Carolina
Study site
Wynnewood, Pennsylvania
Australia3 sites
Study site
Ashford
Study site
Ballarat
Study site
Bedford Park
About this study
Official title: The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.
Read the detailed description
The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.
- Keywords
- Physiologic Pacing, Dual Chamber Pacing, Atrioventricular Block, Bradycardia, Sick Sinus Syndrome
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrioventricular Block, Bradycardia, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | pacemaker patients with previously diagnosed AT. | |
| 2 | pacemaker patients without previously diagnosed AT. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJul 2000
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M. V. Orlov, MD, Principal investigator, Tufts University School of MedicineJ.K. Ghali, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627328
- Sponsor's protocol ID
- 163
- Status last verified
- Feb 2008
- First submitted
- 26 Dec 2007
- Last updated
- 3 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7. doi: 10.1111/j.1540-8159.2007.00772.x.
PubMed 17584266Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.
PubMed 17367361
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients
- ClinicalTrials.gov ID
- NCT00627328
- Acronym / sponsor ID
- 163
- Keywords
- Physiologic Pacing, Dual Chamber Pacing, Atrioventricular Block, Bradycardia, Sick Sinus Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Study completion
- Sep 2004 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.
Detailed description
The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –pacemaker patients with previously diagnosed AT. |
| 2 | – | –pacemaker patients without previously diagnosed AT. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective study with patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications.
Key inclusion criteria (3 listed)
- Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications
- No previous history of pacemaker implantation
- Patients 50 years of age or older
Key exclusion criteria (8 listed)
- Patients with a history of atrial tachyarrhythmias (primary arm of study)
- Patients with medical conditions that would limit study participation
- Patients inaccessible for follow-up at the study center
- Patients incapable of providing Informed Consent
- Patients with NYHA classification of IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
- Background: PubMed 17584266Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7. doi: 10.1111/j.1540-8159.2007.00772.x.
- Results publication: PubMed 17367361Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.
Related trials for Arrhythmia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. V. Orlov, MD principal investigator
Tufts University School of Medicine
J.K. Ghali, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
42 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 42 sites in 3 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 3 inclusion and 8 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 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Australia, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627328, 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 3 Mar 2008.