- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01086098
PACE30: 30 Years in Cardiac Pacing (PACE30)
January 11, 2019 updated by: AChoy, University of Dundee
Trends in Cardiac Pacing - 30 Years of Implants
Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation.
To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort study using record linkage, over a 32 year period.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
5000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with pacemakers
Description
Inclusion Criteria:
- All patients with pacemakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
All paced patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Mortality
Time Frame: 30 years
|
We will examine time to cardiovascular death from pacemaker implant and relate to the differing indications for pacing
|
30 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalisation for heart failure
Time Frame: 30 years
|
We will examine the frequency of hospitalisations after device implantation
|
30 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
March 5, 2010
First Submitted That Met QC Criteria
March 11, 2010
First Posted (Estimate)
March 12, 2010
Study Record Updates
Last Update Posted (Actual)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 11, 2019
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ELD004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pacemakers
-
Rambam Health Care CampusUnknownCARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETICIsrael
-
Deutsches Herzzentrum MuenchenCompletedRecipients of Implantable Pacemakers or DefibrillatorsGermany
-
The Scripps Research InstituteNot yet recruitingImplantable Cardioverter Defibrillator (ICD) | MRI Imaging | Pacemakers
-
Biotronik SE & Co. KGCompletedSafety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDsFrance, Germany, Hungary, Canada, Australia, Austria, Czech Republic, Switzerland
-
Castilla-La Mancha Health ServiceUnknownComplication | Defibrillators | Pacemakers | Pacemaker Electrode Lead FractureSpain
-
University of DundeeCompletedHeart Failure | Cardiac Resynchronisation PacemakersUnited Kingdom
-
University of LeedsNot yet recruitingPacemakers, Heart Failure
-
Biotronik SE & Co. KGCompletedCardiac Resynchronization | Biventricular Pacemakers, Artificial | Cardioverter-Defibrillators, Implantable | Device ReplacementFrance, Hungary, Israel, Spain, Italy, Portugal, Germany, Belgium