INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI (INFINITE-MRI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT01890512
First received: June 25, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled Conditions of Use.


Condition
Bradycardia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit [ Time Frame: one month ] [ Designated as safety issue: No ]

    The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.

    Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:

    1. no episodes of asystole,
    2. no occurrence of sustained ventricular arrhythmias in the bore,
    3. no loss of capture due to rise in pacing threshold.


Enrollment: 20
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ImageReady Pacemaker
patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)

Detailed Description:

Objective of the INFINITE MRI Study is to collect data on the ImageReady MR Conditional Pacing System in subjects undergoing a magnetic resonance scan (MRI).

The ImageReady system has CE mark and enrolled patients will undergo MRI scan under the labeled Conditions of Use. Subjects considered eligible for this studty are already implanted with the system according to standard medical guidelines for PM implantation.

The study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions. The study will collect standard device measurement through device interrogation pre- and post- MRI scan. MRI scan in this study is a non-clinically indicated procedure and is not planned for diagnostic purposes.

Data from this study will be used to support the evidence of clinical performance of the ImageReady™ MR Conditional Pacing System following a MRI scan when used under the labeled Conditions of Use, and may be used to support regulatory submissions for the approval of the system where requested.

The study has no primary endpoint and is not hypothesis driven.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients implanted with a ImageReady pacemakers according to standard medical guidelines in the investigational site or referral centers

Criteria

Inclusion Criteria:

  • Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;
  • Patients already implanted with the ImageReady™ MR Conditional Pacing System, single or dual chamber, including INGENIO™ MRI or ADVANTIO™ MRI pulse generators with FINELINE™ II Sterox or FINELINE II Sterox EZ endocardial lead(s), or accessories (see Table 5.1-1) according to standard medical guidelines for pacemaker implantation;
  • Willing and capable of participation to the procedures indicated in the protocol.

Exclusion Criteria:

  • Patients implanted with pulse generator location outside of left or right pectoral regions;
  • Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
  • Abandoned leads or PGs;
  • Evidence of a fractured lead or compromised PG-lead system integrity;
  • Low life expectancy (< 1 year);
  • Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI;
  • Pregnant women or women of childbearing potential
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890512

Locations
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435CM
ISALA Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Guidant Corporation
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT01890512     History of Changes
Other Study ID Numbers: C1897
Study First Received: June 25, 2013
Results First Received: April 24, 2014
Last Updated: May 26, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014