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

November 27, 2013 updated by: Biotronik SE & Co. KG

Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Allgemeines Krankenhaus Linz
  • Czech Republic
      • Olomouc, Czech Republic
        • University Hospital Olomouc
  • Germany
      • Berlin, Germany
        • St. Gertrauden Krankenhaus
      • Dresden, Germany
        • Städtisches Klinikum Dresden-Friedrichstadt
      • Leipzig, Germany
        • Uniklinik Leipzig
      • Mannheim, Germany
        • Diakoniekrankenhaus Mannheim
      • Neuwied, Germany
        • DRK Krankenhaus Neuwied
  • Switzerland
      • Zürich, Switzerland
        • Stadtspital Triemli
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Cardiology Department, St Thomas' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
3 months
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
1 month
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
1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (ESTIMATE)

October 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Disease

Clinical Trials on Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe