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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01809665




Registration number
NCT01809665
Ethics application status
Date submitted
12/03/2013
Date registered
13/03/2013
Date last updated
2/03/2016

Titles & IDs
Public title
ProMRI PROVEN Master Study
Scientific 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
Secondary ID [1] 0 0
61
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - ICD/CRT-P therapy
Other interventions - MRI

ICD/CRT-P therapy - Standard indication for ICD or triple-chamber pacemaker therapy


Treatment: Devices: ICD/CRT-P therapy


Other interventions: MRI
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
Timepoint [1] 0 0
pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Primary outcome [2] 0 0
Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
Timepoint [2] 0 0
pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Primary outcome [3] 0 0
Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
Timepoint [3] 0 0
pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
St. Poelten
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Canada
State/province [5] 0 0
Edmonton
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Olomouc
Country [7] 0 0
France
State/province [7] 0 0
Brest
Country [8] 0 0
France
State/province [8] 0 0
Tours
Country [9] 0 0
Germany
State/province [9] 0 0
Bonn
Country [10] 0 0
Germany
State/province [10] 0 0
Coburg
Country [11] 0 0
Germany
State/province [11] 0 0
Essen
Country [12] 0 0
Germany
State/province [12] 0 0
Villingen Schwenningen
Country [13] 0 0
Germany
State/province [13] 0 0
Würzburg
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01809665
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wolfgang R. Bauer, Prof.Dr.Dr.
Address 0 0
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01809665