Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs Clinical Trial
Official title:
Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker
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.
| Status | Completed |
| Enrollment | 174 |
| Est. completion date | September 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | |
| Australia | Flinders Medical Center | Bedford Park | South Australia |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Royal Perth Hospital | Perth | |
| Australia | Royal North Shore Hospital | Sydney | |
| Austria | AKH Linz | Linz | |
| Austria | Landesklinikum St. Pölten | St. Poelten | |
| Canada | Royal Alexandra Hospital | Edmonton | |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | CHUS - Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| Czech Republic | University Hospital Olomouc | Olomouc | |
| France | CHU Brest | Brest | |
| France | CHRU de Tours - Hopital Trousseau | Tours | |
| Germany | Universitätsklinikum Bonn | Bonn | |
| Germany | Klinikum Coburg | Coburg | |
| Germany | Elisabeth Krankenhaus Essen | Essen | |
| Germany | Schwarzwald Baar Klinikum Villingen Schwenningen | Villingen Schwenningen | |
| Germany | Medizinische Universitätsklinik Würzburg | Würzburg | |
| Hungary | Semmelweis University | Budapest | |
| Switzerland | Stadtspital Triemli | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Biotronik SE & Co. KG |
Australia, Austria, Canada, Czech Republic, France, Germany, Hungary, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Primary | 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 | Yes | |
| Primary | 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 | Yes |