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
  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:


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 ]

Enrollment: 174
Study Start Date: June 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: February 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
  • Protego ProMRI SD
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Australia, South Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia
Australia
Royal Adelaide Hospital
Adelaide, Australia
Royal Perth Hospital
Perth, Australia
Royal North Shore Hospital
Sydney, Australia
Austria
AKH Linz
Linz, Austria
Landesklinikum St. Pölten
St. Poelten, Austria, 3100
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
CHUS - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Canada
Royal Alexandra Hospital
Edmonton, Canada
Czech Republic
University Hospital Olomouc
Olomouc, Czech Republic
France
CHU Brest
Brest, France
CHRU de Tours - Hopital Trousseau
Tours, France
Germany
Universitätsklinikum Bonn
Bonn, Germany, 53105
Klinikum Coburg
Coburg, Germany
Elisabeth Krankenhaus Essen
Essen, Germany, 45138
Schwarzwald Baar Klinikum Villingen Schwenningen
Villingen Schwenningen, Germany, 78050
Medizinische Universitätsklinik Würzburg
Würzburg, Germany, 97080
Hungary
Semmelweis University
Budapest, Hungary, 1122
Switzerland
Stadtspital Triemli
Zürich, Switzerland
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: October 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines

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

ClinicalTrials.gov processed this record on October 22, 2014