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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

Tracking Information
First Submitted Date October 24, 2011
First Posted Date October 27, 2011
Last Update Posted Date November 28, 2013
Study Start Date March 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2011)
  • 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%.
  • 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
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cardiac Disease
Intervention 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
Study Groups/Cohorts Pacemaker therapy
Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.
Intervention: Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 27, 2013)
121
Original Estimated Enrollment
 (submitted: October 26, 2011)
299
Actual Study Completion Date November 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Czech Republic,   Germany,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01460992
Other Study ID Numbers 49
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor Biotronik SE & Co. KG
Collaborators Not Provided
Investigators
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
PRS Account Biotronik SE & Co. KG
Verification Date November 2013