An observational study in Syncope, Presyncope and Fatigue, sponsored by Abbott Medical Devices. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Abbott Medical Devices · Observational
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 3 is below the median of 221 across 91 observational studies indexed under Syncope.
Browse Syncope studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any study procedures not considered standard of care.
Exclusion Criteria:
Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study.
Radiation: 3T MRI scan
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.
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
Rate of MRI-related adverse events
including but not limited to, the following: * Device (pulse generator) heating resulting in tissue damage in the implant pocket, or patient pocket discomfort, or both. * Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three. * Loss of pacing or capture in the MRI environment.
Time frame: from pre- to 12-month post- MRI scan
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abbott Medical Devices