Heart DiseasesNCT00336011
Safety of Cardiac Pacemakers in 1.5T Tesla MRI
An observational study of Heart Diseases, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2002to Jan 2006
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Urgent need for an MRI examination
- Presence of a Medtronic PM system manufactured between 1993 and 2004
- Stable pacemaker physical parameters
- Battery voltage > 2.7 V
- Battery impedance < 2000 Ohm
- Battery estimated remaining lifetime > 6 months
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- Lead impedances 200-2000 Ohm
- Stable pacing parameters
- Pacing capture threshold <2.5V at a pulse duration of 0.4ms
- Sensing > 5mV
- Minimum 3 months since pacemaker and lead implantation
Who cannot join
- PM system manufacturer other than Medtronic
- History of ventricular tachycardia (VT) or ventricular fibrillation
- Unstable angina
- Myocardial infarction within the previous 3 months
- Cardiothoracic surgery within the previous 3 months
- Complete atrioventricular block
Show all 12Show fewer
- Absolute pacemaker dependence
- Heart rate < 40 bpm or
- Heart rate < 60 bpm producing neurological symptoms
- Presence of an abdominal pacemaker with lead length > 70 cm
- Presence of MRI incompatible bioimplants or other MRI incompatible materials
- Request for an MR examination of the chest, including the heart, breasts and thoracic spine
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Bonn, Department of Radiology
Bonn, North Rhine-Westphalia, 53127
About this study
Official title: Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 1,5 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 1.5T Tesla)
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.
Read the detailed description
The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.
The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.
- Conditions
- Heart Diseases
- Being tested
- Magnetic resonance imaging
- Keywords
- pacemaker, magnetic resonance imaging, safety
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startDec 2002
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Torsten Sommer, MD, Principal investigator, University of Bonn, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336011
- Sponsor's protocol ID
- 186/02
- Status last verified
- Jan 2006
- First submitted
- 9 Jun 2006
- Last updated
- 12 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 1,5 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 1.5T Tesla)
- ClinicalTrials.gov ID
- NCT00336011
- Acronym / sponsor ID
- 186/02
- Conditions
- Heart Diseases
- Keywords
- pacemaker, magnetic resonance imaging, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2002
- Study completion
- Jan 2006
- First posted
- 12 Jun 2006 (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.
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.
Detailed description
The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.
The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Urgent need for an MRI examination
- Presence of a Medtronic PM system manufactured between 1993 and 2004
- Stable pacemaker physical parameters
- Stable pacing parameters
- Minimum 3 months since pacemaker and lead implantation
Key exclusion criteria (12 listed)
- PM system manufacturer other than Medtronic
- History of ventricular tachycardia (VT) or ventricular fibrillation
- Unstable angina
- Myocardial infarction within the previous 3 months
- Cardiothoracic surgery within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging | Device | – |
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 12 Jun 2006.
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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.
Torsten Sommer, MD principal investigator
University of Bonn, Department of Radiology
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 Heart Diseases, run by University Hospital, Bonn at 1 site in Germany.
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 11 inclusion and 12 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 12 Jun 2006. 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 Germany. 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?
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 12 Jun 2006.