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ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads (ProMRIAFFIRM)

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: NCT01460992
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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

Condition or disease Intervention/treatment
Cardiac Disease Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (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

Study Design
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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pacemaker therapy
Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.
 Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
patients will undergo an MRI scan for 30 minutes.
Other Names:
  • Evia/Entovis SR-T (single chamber with telemetry function), DR-T (dual chamber with telemetry function)
  • Atrial/ventricular lead(s): Safio S 53 and S 60.
  • Safio S 45


Outcome Measures
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Primary Outcome Measures :
  1. Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate [ Time Frame: 3 months ]
    MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.

  2. Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular) [ Time Frame: 1 month ]
    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

  3. Primary hypothesis 4: P-wave sensing attenuation [ Time Frame: 1 month ]
    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

  4. Primary hypothesis 5: R-wave sensing attenuation [ Time Frame: 1 month ]
    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.


Eligibility Criteria
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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 investigator's general patient population according to the inclusion and exclusion criteria.
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
Contacts and Locations
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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): NCT01460992


Locations
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Austria
Allgemeines Krankenhaus Linz
Linz, Austria, 4021
Czech Republic
University Hospital Olomouc
Olomouc, Czech Republic
Germany
St. Gertrauden Krankenhaus
Berlin, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany
Uniklinik Leipzig
Leipzig, Germany
Diakoniekrankenhaus Mannheim
Mannheim, Germany
DRK Krankenhaus Neuwied
Neuwied, Germany
Switzerland
Stadtspital Triemli
Zürich, Switzerland
United Kingdom
Cardiology Department, St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Aldo Rinaldi, Dr. Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01460992    
Other Study ID Numbers: 49
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013
Keywords provided by Biotronik SE & Co. KG:
Pacemaker therapy
Magnetic Resonance Imaging (MRI)
EVIA/ENTOVIS
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases