ProMRI Study of the Entovis Pacemaker System
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01761162 |
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Recruitment Status :
Completed
First Posted : January 4, 2013
Results First Posted : November 4, 2014
Last Update Posted : February 9, 2017
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Sponsor:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik, Inc.
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Brief Summary:
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
| Condition or disease | Intervention/treatment |
|---|---|
| Safety of the ProMRI Pacemaker System Under Specific MRI Conditions | Device: Patients with a ProMRI Pacemaker System Other: Magnetic Resonance Imaging (MRI) scan |
| Study Type : | Observational |
| Actual Enrollment : | 229 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | May 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Pacemaker Therapy
Patients with a ProMRI Pacemaker System
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Device: Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat Other: Magnetic Resonance Imaging (MRI) scan MRI scan of head and lower back. |
Primary Outcome Measures :
- MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate [ Time Frame: 1 Month Post-MRI ]
- Percentage of Participants Free of Atrial Pacing Threshold Rise [ Time Frame: Pre-MRI, 1 Month Post-MRI ]Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
- Percentage of Participants Free of Ventricular Pacing Threshold Rise [ Time Frame: Pre-MRI, 1 Month Post-MRI ]Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
- Percentage of Participants Free of P-wave Sensing Attenuation [ Time Frame: Pre-MRI, 1 Month Post-MRI ]Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
- Percentage of Participants Free of R-wave Sensing Attenuation [ Time Frame: Pre-MRI, 1 Month Post-MRI ]Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.
Criteria
Inclusion Criteria:
The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
- Age greater than 18 years
- Subject body height greater than 140 cm (4' 7")
- Able and willing to complete MRI testing
- Able to provide written informed consent
- Available for follow-up visit at the study site
- Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
- Pacemaker implanted pectorally
- All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
- Underling rhythm identifiable during sensing test
- All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
- Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
- Pacing impedance is between 200 and 1500 ohm
- Able and willing to use the Cardio Messenger
At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
- Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
- |pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V
- All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
- The pacemaker system has been implanted for at least 6 weeks.
- Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
- All lead impedances are between 200 and 1500 ohm.
- Battery status is at least 30% of capacity
Exclusion Criteria:
- Enrolled in any other clinical study
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For pacemaker systems that include an atrial lead, subjects with either
- Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
- Permanent atrial arrhythmia
- Life expectancy of less than three months
- Pregnancy
- Cardiac surgery expected in the next three months
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Implanted with other medical devices that may interact with MRI, such as:
- abandoned pacemaker/ICD leads
- lead extensions
- mechanical valves
- other active medical devices
- non-MRI compatible devices
- other metallic artifacts/components in body that may interact with MRI
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761162
Locations
Show 25 study locations
Sponsors and Collaborators
Biotronik, Inc.
Publications of Results:
| Responsible Party: | Biotronik, Inc. |
| ClinicalTrials.gov Identifier: | NCT01761162 |
| Other Study ID Numbers: |
G120226 |
| First Posted: | January 4, 2013 Key Record Dates |
| Results First Posted: | November 4, 2014 |
| Last Update Posted: | February 9, 2017 |
| Last Verified: | December 2016 |