Ingenio Device Algorithm Study

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

Official Title
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Ingenio Device Algorithm Study

Conditions
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Sinus Node Disease, AV Block, Heart Failure

Intervention / Treatment
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* Device: RAAT
* Device: RYTHMIQ


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RYTHMIQ Off at Pre-discharge, On at 1-Month<br>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. | Device: RAAT<br>* For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)<br>Device: RYTHMIQ<br>* For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment<br>|
| Active Comparator: RYTHMIQ On at Pre-Discharge, Off at 1-Month<br>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. | Device: RAAT<br>* For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)<br>Device: RYTHMIQ<br>* For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Commanded Right Atrial Automatic Threshold (RAAT) |  | 3 months post implant | 
| System-related Complication-free rate | a complication related to the system, when the patient is implanted with a pacemaker device a complication related to the system, save for the LV lead, when the patient is implanted with a CRT-P | 90 days post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Ambulatory Right Atrial Automatic Threshold |  | 3 months post-implant | 
| Appropriate RAAT Test Outcome |  | 3 months post-implant | 
| RYTHMIQ | Chronic success for this effectiveness endpoint will be assessed by a median relative reduction of RV pacing percent (RVPP) for RYTHMIQ programmed to ON vs. RYTHMIQ programmed to OFF. All patients will receive both RYTHMIQ programmed to ON and programmed to OFF in two consecutive periods, where the patient's programming allocation will be randomized for the first period. Then a crossover to the alternate setting will occur for the second period once the end of the first period is reached. | 3 months post implant | 
| RAAT Pace Output Margin | The purpose of this endpoint is to demonstrate that the RAAT algorithm produces a sufficient pacing output voltage that is able to capture the right atrium | 3 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, CRT-P, auto threshold