ProMRI PROVEN Master Study

Completed

• Conditions: Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

• Registration Number: NCT01809665
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Study Start: 2013-06
• Primary Completion: 2015-05
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (23)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Flinders Medical Center; 🇦🇺 Bedford Park, South Australia, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Royal Perth Hospital; 🇦🇺 Perth, Australia

Royal North Shore Hospital; 🇦🇺 Sydney, Australia

AKH Linz; 🇦🇹 Linz, Austria

Landesklinikum St. Pölten; 🇦🇹 St. Poelten, Austria

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

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