INGEVITY™ Observational Trial (GENTLE)

Boston Scientific

Status: Completed

Conditions: Bradycardia

Treatments: Device: ImageReady MR Conditional Pacing System Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT02166606

GENTLE-1013

Details and patient eligibility

About

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.

Enrollment: 1,184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,184 participants in 1 patient group

Pacemaker/Lead implant

Description:

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.

Treatment:

Device: ImageReady MR Conditional Pacing System Implant