Ingenio Device Algorithm Study (IVORY)

Boston Scientific

Status: Completed

Conditions: Sinus Node Disease; AV Block; Heart Failure

Treatments: Device: RYTHMIQ; Device: RAAT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01441583

CR-CL-07202011-B-H

Details and patient eligibility

About

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

Full description

IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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139 participants in 3 patient groups

Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month

Active Comparator group

Description:

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.

Treatment:

Device: RYTHMIQ

Device: RAAT

Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month

Active Comparator group

Description:

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.

Treatment:

Device: RYTHMIQ

Device: RAAT

CRT-P

Experimental group

Description:

CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT.

Treatment:

Device: RAAT