ProMRI PROVEN Master Study

Biotronik

Status: Completed

Conditions: Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

Treatments: Other: MRI; Device: ICD/CRT-P therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01809665

61

Details and patient eligibility

About

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Able and willing to complete MRI testing
• Able and willing to activate and use the Cardio Messenger
• Able and willing to complete all testing required by the clinical protocol
• Available for all follow-up visits at the investigational site
• Standard indication for single, dual, or triple chamber ICD or CRT-P.
• ICD or CRT-P system to be implanted in the pectoral region
• Patient body height ≥ 140 cm
• Age ≥ 18 years

Exclusion criteria

• Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
• Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
• Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
• Patient has other metallic artifacts / components in body that may interact with MRI
• Life expectancy of less than eight months
• Cardiac surgery in the next eight months
• Pregnant or breastfeeding
• Enrolled in another non-observational cardiac clinical investigation

Trial design

174 participants in 1 patient group

ICD/CRT-P therapy

Description:

Standard indication for ICD or triple-chamber pacemaker therapy

Treatment:

Other: MRI

Device: ICD/CRT-P therapy