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ProMRI PROVEN Master Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01809665
First received: March 12, 2013
Last updated: October 14, 2014
Last verified: October 2014

March 12, 2013
October 14, 2014
June 2013
February 2015   (final data collection date for primary outcome measure)
  • The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI [ Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI ] [ Designated as safety issue: Yes ]
  • Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI [ Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI ] [ Designated as safety issue: Yes ]
  • Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI. [ Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01809665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ProMRI PROVEN Master Study
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
  • Device: ICD/CRT-P therapy
    Other Names:
    • Ilesto 7/5
    • Iforia 7/5
    • Evia HF-T
    • Entovis HF-T
    • Solia S
    • Solia T
    • Linoxsmart ProMRI S, SD or S DX
    • Linoxsmart ProMRI DF4 SD
    • Corox ProMRI OTW BP, -S BP or -L BP
    • Protego ProMRI SD
  • Other: MRI
ICD/CRT-P therapy
Standard indication for ICD or triple-chamber pacemaker therapy
Interventions:
  • Device: ICD/CRT-P therapy
  • Other: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
174
November 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Switzerland
 
NCT01809665
61
Yes
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Principal Investigator: Wolfgang R. Bauer, Prof.Dr.Dr. Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Biotronik SE & Co. KG
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP