ProMRI PROVEN Master Study
- Conditions
- Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
- Interventions
- Device: ICD/CRT-P therapyOther: MRI
- Registration Number
- NCT01809665
- Lead Sponsor
- Biotronik SE & Co. KG
- 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) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICD/CRT-P therapy MRI Standard indication for ICD or triple-chamber pacemaker therapy ICD/CRT-P therapy ICD/CRT-P therapy Standard indication for ICD or triple-chamber pacemaker therapy
- Primary Outcome Measures
Name Time Method The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI. pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Flinders Medical Center
🇦🇺Bedford Park, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Royal Perth Hospital
🇦🇺Perth, Australia
Royal North Shore Hospital
🇦🇺Sydney, Australia
Landesklinikum St. Pölten
🇦🇹St. Poelten, Austria
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
CHU Brest
🇫🇷Brest, France
University Hospital Olomouc
🇨🇿Olomouc, Czech Republic
CHRU de Tours - Hopital Trousseau
🇫🇷Tours, France
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Schwarzwald Baar Klinikum Villingen Schwenningen
🇩🇪Villingen Schwenningen, Germany
Elisabeth Krankenhaus Essen
🇩🇪Essen, Germany
Medizinische Universitätsklinik Würzburg
🇩🇪Würzburg, Germany
Semmelweis University
🇭🇺Budapest, Hungary
Stadtspital Triemli
🇨🇭Zürich, Switzerland
AKH Linz
🇦🇹Linz, Austria
Royal Alexandra Hospital
🇨🇦Edmonton, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
CHUS - Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada