Ingenio Device Algorithm Study (IVORY)
Sinus Node Disease, AV Block, Heart Failure
About this trial
This is an interventional treatment trial for Sinus Node Disease focused on measuring pacemaker, CRT-P, auto threshold
Eligibility Criteria
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 would be unusually difficult or burdensome for the subject;
- Inability or refusal to comply with the FU schedule;
- A life expectancy of less than 12 months, per physician discretion;
- Subjects who are planned to be programmed to a pacing mode other than DDD / DDDR during the study period.
Sites / Locations
- Wilhelminenspital
- Landesklinikum Wiener Neustadt
- Clinique Universitaires Saint Luc
- Rigshospitalet Copenhagen
- Gentofte University Hospital
- NCN Nouvelles Cliniques Nantaises
- Clinique Saint-Hilaire Rouen
- Krankenhaus Neu Bethlehem
- Heinrich Braun Krankenhaus
- Prince of Wales Hospital
- Azienda Ospedaliera Mater Domini Policlinico Universitario
- Policlinico Casilino
- Institut Jantung Negara
- Amphia Ziekenhuis
- Rijnland Ziekenhuis
- Hospital Clinico Y Provincial
- Clinica Universitaria de Navarra
- Sahlgrenska University Hospital
- Karolinska Hospital
- Golden Jubilee National Hospital
- Northern General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
RYTHMIQ Off at Pre-discharge, On at 1-Month
RYTHMIQ On at Pre-Discharge, Off at 1-Month
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ Off at Pre-Discharge will have RYTHMIQ programmed Off until their 1-month follow up, when they will be crossed over to RYTHMIQ On until their 3-month follow up.
For the RYTHMIQ endpoint only, subjects implanted with a pacemaker will be randomized. Those randomized to RYTHMIQ On at Pre-Discharge will have RYTHMIQ programmed On until their 1-month follow up, when they will be crossed over to RYTHMIQ Off until their 3-month follow up.