Heart DiseasesNCT00356330
Safety of Cardiac Pacemakers in 3 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 at 3T on the technical and functional status of cardiac pacemakers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Urgent need for an MRI examination
- Stable pacemaker physical parameters
- Battery voltage > 2.7 V
- Battery impedance < 2000 Ohm
- Battery estimated remaining lifetime > 6 months
- Lead impedances 200-2000 Ohm
Show all 10Show fewer
- 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
- History of ventricular tachycardia (VT) or ventricular fibrillation
- Unstable angina
- Myocardial infarction within the previous 3 months
- Cardiothoracic surgery within the previous 3 months
- Presence of an abdominal pacemaker with lead length > 70 cm
- Presence of MRI incompatible bioimplants or other MRI incompatible materials
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Bonn, Department of Radiology
Bonn, North Rhine-Westphalia, 53127
Torsten Sommer, MD, +49-163-7113875, t.sommer@uni-bonn.de
Claas P Naehle, MD, +49-178-4001619, cp@naehle.net
About this study
Official title: Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.
Read the detailed description
Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.
Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.
In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.
- Conditions
- Heart Diseases
- Keywords
- pacemaker, magnetic resonance imaging, safety
- Medical subject headings
- Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
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
- Investigators
- Torsten Sommer, MD, Principal investigator, University of Bonn, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356330
- Sponsor's protocol ID
- 116/06
- Status last verified
- Apr 2007
- First submitted
- 25 Jul 2006
- Last updated
- 11 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla
- ClinicalTrials.gov ID
- NCT00356330
- Acronym / sponsor ID
- 116/06
- Conditions
- Heart Diseases
- Keywords
- pacemaker, magnetic resonance imaging, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- First posted
- 26 Jul 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 at 3T on the technical and functional status of cardiac pacemakers.
Detailed description
Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.
Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.
In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Urgent need for an MRI examination
- Stable pacemaker physical parameters
- Stable pacing parameters
- Minimum 3 months since pacemaker and lead implantation
Key exclusion criteria (6 listed)
- History of ventricular tachycardia (VT) or ventricular fibrillation
- Unstable angina
- Myocardial infarction within the previous 3 months
- Cardiothoracic surgery within the previous 3 months
- Presence of an abdominal pacemaker with lead length > 70 cm
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
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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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Apr 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torsten Sommer, MD (+49-163-6113875, t.sommer@uni-bonn.de), or a site near the patient. 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 11 Apr 2007.