The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study;
* Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law;
* Subjects indicated for a dual chamber pacemaker or a CRT-P device according to class I or class II indications of the standard ESC or ACC / AHA implant guidelines;
* Subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, CRT-P: atrial, right and left ventricular lead) or are already implanted with such leads;
* Subjects who receive or are implanted with a bipolar atrial lead.
Exclusion Criteria:
* Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion);
* Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect
* Schedule of procedures for IVORY (i.e. should not cause additional or missed visits);
* Programming of devices for IVORY per CIP;
* IVORY outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of IVORY per GCP / ISO 14 155:2011 / local regulations.
* Subjects who live at such a distance from the clinic that travels for FU visits at a study center w…
What they're measuring
1
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)