Clinical trial NCT01460992: ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
Official title: Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Pacemaker therapy
Magnetic Resonance Imaging (MRI)
EVIA/ENTOVIS
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Brief summary: This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
* The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
* Age more than 18 years
* Understand the nature of the procedure
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Give written informed consent
* Able to complete all testing required by the clinical protocol
* Ability to measure atrial and/or ventricular pacing threshold(s)\* (at 0.4 ms)
* All pacing thresholds do not exceed 2.0V @0.4ms.
* Available for follow-up visit at the investigational site
* Patient body height greater or equal to 140 cm
* Pectoral implantation
* The ascertained lead impedance is between 200 and 1500 Ohms.

Exclusion Criteria:

* No EVIA/ENTOVIS /Safio S pacemaker system implanted
* Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
* Meet one or more of the contraindications
* Being pregnant
* Have a life expectancy of less than three months
* Cardiac surgery already scheduled in the next three months
* Enrolled in another cardiac clinical investigation
* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)
* Have other metallic artifacts/components in body that may interact with MRI

Primary outcomes:
measure: Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate
timeFrame: 3 months
measure: Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)
timeFrame: 1 month
measure: Primary hypothesis 4: P-wave sensing attenuation
timeFrame: 1 month
measure: Primary hypothesis 5: R-wave sensing attenuation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Berlin
country: Germany
facility: St. Gertrauden Krankenhaus
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
city: Leipzig
country: Germany
facility: Uniklinik Leipzig
city: Mannheim
country: Germany
facility: Diakoniekrankenhaus Mannheim
city: Neuwied
country: Germany
facility: DRK Krankenhaus Neuwied
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: London
country: United Kingdom
facility: Cardiology Department, St Thomas' Hospital
Study officials:
affiliation: Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk
name: Aldo Rinaldi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.