Trials / Completed
CompletedNCT01809665
ProMRI PROVEN Master Study
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 174 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ICD/CRT-P therapy | |
| OTHER | MRI |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-05-01
- Completion
- 2015-09-01
- First posted
- 2013-03-13
- Last updated
- 2016-03-02
Locations
23 sites across 8 countries: Australia, Austria, Canada, Czechia, France, Germany, Hungary, Switzerland
Source: ClinicalTrials.gov record NCT01809665. Inclusion in this directory is not an endorsement.