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ProMRI PROVEN Master Study

This study is not yet open for participant recruitment.
Verified May 2013 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01809665
First received: March 12, 2013
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
 Device: ICD/CRT-P therapy
Other: MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 590
Study Start Date: May 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD/CRT-P therapy
Standard indication for ICD or triple-chamber pacemaker therapy
 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
Other: MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809665

Contacts
Contact: Simone Frömer +493068905 ext 1243 simone.froemer@biotronik.com

  Show 26 Study Locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Wolfgang R. Bauer, Prof. Dr. Dr. Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01809665     History of Changes
Other Study ID Numbers: 61
Study First Received: March 12, 2013
Last Updated: May 8, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Canada: Health Canada
France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins

Keywords provided by Biotronik SE & Co. KG:
ICD therapy
CRT-P therapy
MRI

ClinicalTrials.gov processed this record on May 16, 2013