BradycardiaNCT00294060
P3: Pacemaker Patient Profiling Study
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 83 sites in United States.
Trial summary
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- How many people
- 2,013 participants
- Where
- 83 sitesUnited States
- Study dates
- Mar 2004to Nov 2007
- Phase
- Observational
- 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
Study population: Primary care clinic
Who may be able to join
- Patient meets Class I / Class II indications for pacing
- Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
Who cannot join
- Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
- Patient whose life expectancy is less than two years
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Study site
Aliso Viejo, California
Study site
Alpena, Michigan
Study site
Anaheim, California
Study site
Arcadia, California
Study site
Austin, Texas
Study site
Beaumont, Texas
Study site
Billings, Montana
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Bridgewater, New Jersey
Study site
Cambridge, Massachusetts
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Cleveland, Mississippi
Study site
Cleveland, Ohio
Study site
Cleveland Heights, Ohio
Study site
Clifton, New Jersey
Study site
Columbus, Ohio
Study site
Denver, Colorado
Study site
Dublin, Ohio
Study site
Durham, North Carolina
Study site
Edgewood, Kentucky
Study site
Elizabeth, New Jersey
Study site
Elmira, New York
Study site
Escondido, California
Study site
Fort Lauderdale, Florida
Study site
Fountain Valley, California
Study site
Galloway, New Jersey
Study site
Greenville, South Carolina
Study site
Hammond, Indiana
Study site
Hinsdale, Illinois
Study site
Houston, Texas
Study site
Humble, Texas
Study site
Huntington, New York
Study site
Hutchinson, Kansas
Study site
Idaho Falls, Idaho
Study site
Kearney, Nebraska
Study site
Kettering, Ohio
Study site
La Crosse, Wisconsin
Study site
La Mesa, California
Study site
Lafayette, Louisiana
Study site
Laguna Hills, California
Study site
Lauderdale Lakes, Florida
Study site
Lawrenceville, Georgia
Study site
Lima, Ohio
Study site
Little Rock, Arkansas
Study site
Lorain, Ohio
Study site
Lubbock, Texas
Study site
Mayfield Heights, Ohio
Study site
McAllen, Texas
Study site
Melbourne, Florida
Study site
Middleburg Heights, Ohio
Study site
Mission Viejo, California
Study site
Moberly, Missouri
Study site
Moline, Illinois
Study site
New Orleans, Louisiana
Study site
Ocala, Florida
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Osage Beach, Missouri
Study site
Owensboro, Kentucky
Study site
Prescott, Arizona
Study site
Riverside, California
Study site
Rockville, Maryland
Study site
Saint Joseph, Missouri
Study site
San Antonio, Texas
Study site
Sarasota, Florida
Study site
Scarborough, Maine
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
Sumter, South Carolina
Study site
Tarzana, California
Study site
Terre Haute, Indiana
Study site
Tomball, Texas
Study site
Tulsa, Oklahoma
Study site
Vero Beach, Florida
Study site
Victoria, Texas
Study site
Wakefield, Rhode Island
Study site
Waukesha, Wisconsin
Study site
Whittier, California
Study site
Wichita Falls, Texas
Study site
Wildomar, California
Study site
Zanesville, Ohio
About this study
Official title: Pacemaker Patient Profiling (P3) Study
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
- Conditions
- Bradycardia
- Keywords
- Pacemaker, Bradycardia
- Medical subject headings
- Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dual Chamber Devices
Pacemaker device choice characterized by the number of patients with dual chamber devices
Measured: at original implant
Days Hospitalized
Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year
Measured: implant to one year
Multiple In-clinic Visits
Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation
Measured: implant to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies 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
- 2,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ravi Kanagala, MD, Study chair, Franciscan Skemp Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294060
- Sponsor's protocol ID
- 244
- Status last verified
- Apr 2011
- First submitted
- 16 Feb 2006
- Last updated
- 6 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacemaker Patient Profiling (P3) Study
- ClinicalTrials.gov ID
- NCT00294060
- Acronym / sponsor ID
- 244
- Conditions
- Bradycardia
- Keywords
- Pacemaker, Bradycardia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.
- Enrolment
- 2,013 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Patient meets Class I / Class II indications for pacing
- Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
Key exclusion criteria (2 listed)
- Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
- Patient whose life expectancy is less than two years
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
Number of Participants With Dual Chamber Devices
Time frame: at original implant
Pacemaker device choice characterized by the number of patients with dual chamber devices
Days Hospitalized
Time frame: implant to one year
Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year
Multiple In-clinic Visits
Time frame: implant to one year
Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bradycardia
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SPIKE FLOW Endocardial Lead Safety and Performance Study
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Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
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Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia
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.
Ravi Kanagala, MD study chair
Franciscan Skemp Healthcare
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 83 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 2 inclusion and 2 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 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 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 6 May 2011). 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?
Number of Participants With Dual Chamber Devices (time frame: at original implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2011.