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This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.
The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker therapy | Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions | Procedure | patients will undergo an MRI scan for 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate | MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%. | 3 months |
| Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular) | The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up | 1 month |
| Primary hypothesis 4: P-wave sensing attenuation | P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV | 1 month |
| Primary hypothesis 5: R-wave sensing attenuation | R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Aldo Rinaldi, Dr. | Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Linz | Linz | 4021 | Austria | |||
| University Hospital Olomouc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25680307 | Derived | Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Olomouc |
| Czechia |
| St. Gertrauden Krankenhaus | Berlin | Germany |
| Städtisches Klinikum Dresden-Friedrichstadt | Dresden | Germany |
| Uniklinik Leipzig | Leipzig | Germany |
| Diakoniekrankenhaus Mannheim | Mannheim | Germany |
| DRK Krankenhaus Neuwied | Neuwied | Germany |
| Stadtspital Triemli | Zurich | Switzerland |
| Cardiology Department, St Thomas' Hospital | London | SE1 7EH | United Kingdom |