Status:
COMPLETED
ProMRI PROVEN Master Study
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
Eligibility:
All Genders
18+ years
Brief Summary
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01809665
Start Date
June 1 2013
End Date
September 1 2015
Last Update
March 2 2016
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
2
Flinders Medical Center
Bedford Park, South Australia, Australia
3
Box Hill Hospital
Box Hill, Victoria, Australia
4
Royal Adelaide Hospital
Adelaide, Australia