Safety of MR (Magnetic Resonance)-Conditional ICDs Clinical Trial
Official title:
ProMRI 3T ENHANCED Master Study
| Verified date | February 2018 |
| Source | Biotronik SE & Co. KG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | January 15, 2018 |
| Est. primary completion date | January 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP) - ICD system was implanted in the pectoral region - Implantation at least 5 weeks prior to enrollment date - Patient body height = 140 cm - Age = 18 years - Right Ventricular pacing threshold (at 0.4 ms) measurable and = 2.0 V - Written informed consent - Able and willing to complete MRI testing - Able and willing to complete all testing required by the clinical protocol - Available for all follow-up visits at the investigational site Exclusion Criteria: - Standard contraindication for MRI scans - Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant - Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date - Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS) - MRI scan within 5 weeks prior to enrollment date - R-wave sensing amplitude < 6.5 millivolt - Lead impedance less than 200 or greater than 1500 Ohm - Life expectancy of less than six months - Cardiac surgery in the next six months - Pregnant or breastfeeding - Participation in another interventional clinical investigation |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Flinders Medical Centre | Bedford Park | |
| Australia | Royal North Shore Hospital | Sydney | |
| Australia | Westmead Hospital | Westmead | |
| Austria | Allgemeines Krankenhaus Linz | Linz | |
| Austria | Landesklinikum St. Pölten | St. Pölten | |
| Germany | Deutsches Herzzentrum Berlin | Berlin | |
| Germany | Klinikum Coburg | Coburg | |
| Germany | Uniklinikum Düsseldorf | Düsseldorf | |
| Germany | Universitätsklinikum Göttingen | Göttingen | |
| Germany | St. Bonifatius Hospital | Lingen | |
| Singapore | National Heart Centre | Singapore | |
| Switzerland | Stadtspital Triemli | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Biotronik SE & Co. KG |
Australia, Austria, Germany, Singapore, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure | 1 Month | ||
| Primary | Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI | Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI | 1 Month | |
| Primary | Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI | Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI | 1 Month |