Overview

This trial is active, not recruiting.

Condition bradycardia
Treatment imageready mr conditional pacing system implant
Sponsor Boston Scientific Corporation
Start date April 2014
End date June 2016
Trial size 1177 participants
Trial identifier NCT02166606, GENTLE-1013

Summary

The objectives of this registry are to

1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events

2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.

3. Collect physician feedback on lead handling with the INGEVITY lead

in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an "all-comers" consecutive basis.
imageready mr conditional pacing system implant
Implant according to standard-of-care. No study-specific interventions in that registry.

Primary Outcomes

Measure
Number of patients with a Serious Adverse Device Effect during the first 3 months post implant
time frame: 91 calendar days post-implant

Secondary Outcomes

Measure
Number of patients with a specific Serious Adverse Device Effect types during the first 3 months post implant
time frame: 91 calendar days post implant
Number of patients with MRI procedure performed as a measure of the real-world frequency of MRI procedures in a pacemaker population including collection of information on scanned body parts
time frame: 365 calendar days post implant
Physician implant handling survey scores as a measure of physician satisfaction
time frame: Day 0 as defined in CIP

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject is willing and capable of providing informed consent and to give approval to collect / store / process personal health information by the sponsor - Subject is scheduled for, or implanted with, a clinically indicated BSC ImageReady system according to current and locally applicable implant guidelines such as published by European Society of Cardiology (ESC) / American Heart Association (AHA) / American College of Cardiology (ACC) / Hearth Rhythm Society (HRS) - Subject is geographically stable to be available for follow up at an approved registry center during the whole registry duration - Subject is age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: - Existing contraindications for a BSC ImageReady system as mentioned in the applicable reference guides of the implanted system components including a known or suspected sensitivity to dexamethasone acetate (DXA) - Implanted pacing system is not ImageReady, i.e. any system components other than BSC INGEVITY MRI Conditional leads (or their market released successors), BSC INGENIO MRI family pacemaker models and their accessories (or their market released successors) intended to have MR Conditional status, including pre-existing abandoned leads of any kind still implanted and which will not be removed during the implant or re-implant procedure or plugged lead ports - Any existing conditions per local standard of care preventing the subject from undergoing an MRI procedure including implanted active or inactive medical devices / material, not considered MR Conditional - Subject is enrolled in any other concurrent study with the exception of local mandatory governmental registries and studies/registries that are not in conflict and do not affect the following: 1. GENTLE registry outcome (i.e. involve different implantable system components than required for participation in GENTLE or would affect ability to undergo MRI procedures); 2. Conduct of the GENTLE Registry per Good Clinical Practice (GCP)/ ISO (International Organization of Harmonization) 14155:2011/ local regulations as applicable - Subject is a woman of childbearing potential who is, or might be, pregnant at the time of registry enrollment or plans to become pregnant during the course of the registry (based on physician's assessment) - Estimated life expectancy of less than twelve months per physician discretion

Additional Information

Official title INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing
Principal investigator Daniel Gras, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.