Completed

NCT Number: NCT01809665

ProMRI PROVEN Master Study

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICD/CRT-P therapy

Device

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

MRI

Other

Primary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Mar 13, 2013
Registry last updated: Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.