INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI

NCT01890512 | Completed Results

• 1 other identifier: C1897
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit

  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.

  one month

Study Arms (1)

ImageReady Pacemaker

patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

ISALA Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Giovanni Raciti
• Organization: Guidant Europe SA/NV A Boston Scientific Company

giovanni.raciti@bsci.com

+39 02 26983213

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 1, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 5, 2016
• Results First Posted: June 5, 2014

Record last verified: 2014-05

Locations

NL (2)