N/A
N=136
Ingenio Device Algorithm Study
Sinus Node Disease · AV Block · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01441583 ↗Enrolled (actual)
136
Serious AEs
38.2%
Results posted
Mar 2024
Primary outcome: Primary: Accuracy of Commanded Right Atrial Automatic Threshold (RAAT) — 100 percentage of accurate RAAT tests
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RAAT (Device); RYTHMIQ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Commanded Right Atrial Automatic Threshold (RAAT) |
100 | — |
| PRIMARY System-related Complication-free Rate |
87.5 | — |
| SECONDARY Accuracy of Ambulatory RAAT |
186 | — |
| SECONDARY Appropriate RAAT Test Outcome |
84.7 | — |
| SECONDARY RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ Off at Pre-discharge, On at 1-Month |
4; 98 | — |
| SECONDARY Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin |
100 | — |
Summary
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
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.
Data sourced from ClinicalTrials.gov (NCT01441583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.