Cardiac Pacemaker, ArtificialNCT01009320
The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers
An observational study of Cardiac Pacemaker, Artificial, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Pacemaker, Artificial
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Nov 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Out-patient clinic
Who may be able to join
- Cardiac pacemaker
Who cannot join
- Unstable angina
- Hemodynamic instability
- Subjects whom the cardiologist believes are unsuitable for asynchronous pacing
Trial locations and contacts
1 site in 1 country.
About this study
Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.
- Conditions
- Cardiac Pacemaker, Artificial
- Keywords
- Pacemaker, Magnets, Drape, Ferrite, Magnetic field, Pacemaker interference
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 |
|---|---|---|
| Pacemaker with magnets | Patients with pacemakers who will be tested for magnetic interference with a magnetic drape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchronous pacing
Measured: Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacemaker, ArtificialStudies 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
- Investigators
- Louis-Philippe Fortier, MD, FRCPC, Study director, Maisonneuve-Rosemont hospital, University of MontrealValerie Zaphiratos, MD, Principal investigator, Maisonneuve-Rosemont hospital, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009320
- Sponsor's protocol ID
- HMRvzaphi
- Other IDs
- 09051
- Status last verified
- Mar 2013
- First submitted
- 5 Nov 2009
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers
- ClinicalTrials.gov ID
- NCT01009320
- Acronym / sponsor ID
- HMRvzaphi
- Conditions
- Cardiac Pacemaker, Artificial
- Keywords
- Pacemaker, Magnets, Drape, Ferrite, Magnetic field, Pacemaker interference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Nov 2009 (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.
Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker with magnets | – | –Patients with pacemakers who will be tested for magnetic interference with a magnetic drape. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patient clinic
Key inclusion criteria (1 listed)
- Cardiac pacemaker
Key exclusion criteria (3 listed)
- Unstable angina
- Hemodynamic instability
- Subjects whom the cardiologist believes are unsuitable for asynchronous pacing
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
Asynchronous pacing
Time frame: Minutes
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 6 Mar 2013.
Related trials for Cardiac Pacemaker, Artificial
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Not yet recruitingObservational study
Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Pain Measurement, Chronic Pain
Not yet recruitingObservational study
Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
Atrial Fibrillation, Atrioventricular Block, Second and Third Degree
Enrolling by invitationObservational study
OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence
Heart Failure, Pacemaker
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.
Louis-Philippe Fortier, MD, FRCPC study director
Maisonneuve-Rosemont hospital, University of Montreal
Valerie Zaphiratos, MD principal investigator
Maisonneuve-Rosemont hospital, University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Pacemaker, Artificial, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 1 inclusion and 3 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 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does the primary outcome measure?
Asynchronous pacing (time frame: Minutes). 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 Mar 2013.