The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts. 3. Collect physician feedback on lead handling with the INGEVITY lead in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.
Study Type
OBSERVATIONAL
Enrollment
1,184
Implant according to standard-of-care. No study-specific interventions in that registry.
Medizinische Universitat Graz
Graz, Austria
AKh - Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, Austria
Ziekenhaus Oost Limburg
Genk, Belgium
Grand Hopital De Charleroi
Gilly, Belgium
Jessa Hospital
Hasselt, Belgium
UCL de Mont Godinne
Percentage of Leads Free From Complication
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.
Time frame: 91 calendar days post-implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yvoir, Belgium
Clinique Rhone Durance
Avignon, France
Hopital Prive Saint Martin
Caen, France
Centre Hospitalier du Contentin
Cherbourg, France
Centre Hospitalier de Marne La Vallee
Jossigny, France
...and 50 more locations