Status:
COMPLETED
Ingenio Device Algorithm Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Sinus Node Disease
AV Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Detailed Description
IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01441583
Start Date
October 1 2011
End Date
April 1 2013
Last Update
March 21 2024
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Wilhelminenspital
Vienna, Austria, 1160
2
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria, 2700
3
Clinique Universitaires Saint Luc
Brussels, Belgium, 1200
4
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100