Clinical trial NCT01809665: ProMRI PROVEN Master Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
Keywords: ICD therapy
CRT-P therapy
MRI
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
timeFrame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
measure: Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
timeFrame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
measure: Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
timeFrame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Linz
country: Austria
facility: AKH Linz
city: St. Poelten
country: Austria
facility: Landesklinikum St. Pölten
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Brest
country: France
facility: CHU Brest
city: Tours
country: France
facility: CHRU de Tours - Hopital Trousseau
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Villingen Schwenningen
country: Germany
facility: Schwarzwald Baar Klinikum Villingen Schwenningen
city: Würzburg
country: Germany
facility: Medizinische Universitätsklinik Würzburg
city: Budapest
country: Hungary
facility: Semmelweis University
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
name: Wolfgang R. Bauer, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
References: