ProMRI PROVEN Master Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 4, 2013
Last verified: September 2013
  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 ]

Estimated Enrollment: 590
Study Start Date: June 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
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

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

  Hide Study Locations
Locations
Australia, New South Wales
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia
Principal Investigator: Raymond Sy, Dr.         
Prince of Wales Hospital Not yet recruiting
Randwick, New South Wales, Australia
Principal Investigator: Robert Giles, Dr.         
Australia, South Australia
Flinders Medical Center Recruiting
Bedford Park, South Australia, Australia
Principal Investigator: Andrew McGavigan         
Australia, Victoria
Box Hill Hospital Not yet recruiting
Box Hill, Victoria, Australia
Principal Investigator: Angas Hamer, Dr.         
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia
Principal Investigator: Justin Mariani, Dr.         
Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, Australia
Principal Investigator: Prashanthan Sanders, Prof.         
Royal Brisbane and Women's Hospital Not yet recruiting
Herston, Australia
Principal Investigator: Karin KM Chia, MBBS         
Royal Perth Hospital Not yet recruiting
Perth, Australia
Principal Investigator: Vince Paul, Dr.         
Austria
Landesklinikum St. Pölten Not yet recruiting
St. Poelten, Austria, 3100
Principal Investigator: Christian Wollmann, Dr.         
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Eugene Crystal, Dr.         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Douglas Cameron, Dr.         
Canada, Quebec
CHUS - Centre hospitalier universitaire de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada
Principal Investigator: Felix Ayala-Paredes, Dr.         
Czech Republic
University Hospital Olomouc Not yet recruiting
Olomouc, Czech Republic
Contact: Milos Taborsky, Dr. med.       milos.taborsky@seznam.cz   
Contact: Zbynék Tüdös, Dr. med.       Zbynek.tudos@seznam.cz   
Principal Investigator: Milos Taborsky, Dr. med.         
France
CHRU de Tours - Hopital Trousseau Not yet recruiting
Tours, France
Principal Investigator: Dominique Babuty, Prof.         
Germany
Charitè Berlin Not yet recruiting
Berlin, Germany
Principal Investigator: Christoph Melzer, Dr.         
Universitätsklinikum Bonn Not yet recruiting
Bonn, Germany, 53105
Principal Investigator: Jörg-Otto Schwab, Prof. Dr.         
Klinikum Coburg Not yet recruiting
Coburg, Germany
Principal Investigator: Johannes Brachmann, Prof. Dr.         
Elisabeth Krankenhaus Essen Not yet recruiting
Essen, Germany, 45138
Principal Investigator: Dietmar Schmitz, Dr.         
Robert-Bosch Krankenhaus Not yet recruiting
Stuttgart, Germany
Principal Investigator: Stephan Hill, Dr.         
Schwarzwald Baar Klinikum Villingen Schwenningen Recruiting
Villingen Schwenningen, Germany, 78050
Principal Investigator: Werner Jung, Dr.         
Medizinische Universitätsklinik Würzburg Not yet recruiting
Würzburg, Germany, 97080
Principal Investigator: W.R. Bauer, Prof. Dr. Dr.         
Hungary
Semmelweis University Not yet recruiting
Budapest, Hungary, 1122
Principal Investigator: Béla Merkely, Prof. Dr.         
The University of Pecs Not yet recruiting
Pecs, Hungary, 7624
Principal Investigator: T. Simor, Assoc. Prof. Dr.         
New Zealand
Auckland City Hospital Not yet recruiting
Auckland, New Zealand
Principal Investigator: Nigel Lever, Dr.         
Slovakia
VUSCH East Slovak Cardiology Institute Not yet recruiting
Kosice, Slovakia, 04001
Principal Investigator: Branislav Stančák, MUDr.         
Switzerland
Stadtspital Triemli Not yet recruiting
Zürich, Switzerland
Contact: Rainer Zbinden, Dr. med.       rainer.zbinden@triemli.stzh.ch   
Contact: Christopher Beynon, d       christopher.beynon@triemli.stzh.ch   
Principal Investigator: Rainer Zbinden, Dr. med.         
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: September 4, 2013
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

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

ClinicalTrials.gov processed this record on August 21, 2014