The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.
This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.
Study Type
OBSERVATIONAL
Enrollment
3
A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.
Tartu University Hospital
Tartu, Estonia
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, France
CHRU Hopital de Pontchaillou
Rennes, Brittany Region, France
Care Institute of Medical Sciences
Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width
Time frame: from pre- MRI scan to one-month post MRI scan
Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan
Time frame: from pre-MRI scan to one-month post-MRI scan
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Ahmedabad, Gurarat, India
Eternal Haert Care Centre
Jaipur, Rajasthan, India
Apollo Hospital
Chennai, Tamil Nadu, India
AOU Federico II - Università degli Studi di Napoli
Napoli, Campania, Italy
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Albert Schweiter Ziekenhuis
Dordrecht, South Holland, Netherlands