Ingenio Device Algorithm Study

Not Applicable

Completed

Conditions: Sinus Node Disease
AV Block
Heart Failure

Interventions: Device: RAAT
Device: RYTHMIQ

Registration Number: NCT01441583

Lead Sponsor: Boston Scientific Corporation

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 139

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month	RAAT	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.
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month	RYTHMIQ	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.
Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month	RYTHMIQ	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.
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month	RAAT	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.
CRT-P	RAAT	CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT.

Primary Outcome Measures

Name	Time	Method
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)	3 months post implant	Accuracy was evaluated by the proportion of tests resulting in an RAAT commanded threshold with \\|Manual unipolar threshold - commanded threshold\\| ≤ 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the manual unipolar threshold and the commanded threshold obtained at a visit.
System-related Complication-free Rate	90 days post-implant	Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population and both pacemakers and CRT-P devices were pooled for the analysis. The analysis assesses the system-related complication (SRC) -free rate (excluding LV related events for CRT-P subjects) for subjects implanted or attempted to be implanted with a study device through the first 90 days following the implant procedure.

Secondary Outcome Measures

Name	Time	Method
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	3 months post implant	Chronic success is assessed by a median relative reduction of RV pacing percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ On at Pre-Discharge, Off at 1-Month. All patients received both RYTHMIQ programmed to ON and programmed to OFF in two consecutive periods, where the patient's programming allocation was randomized for the first period. Then a crossover to the alternate setting occurred for the second period once the end of the first period was reached.
Accuracy of Ambulatory RAAT	3 months post-implant	Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population (pacemaker and CRT-P). Accuracy was evaluated by the proportion of tests resulting in an RAAT ambulatory threshold with \\|ambulatory threshold - commanded threshold\\| ≤ 1.0V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted consisted of the ambulatory threshold obtained within 7 days prior to the visit and the commanded threshold obtained at the visit.
Appropriate RAAT Test Outcome	3 months post-implant	Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population (pacemaker and CRT-P). Accuracy was evaluated by the proportion of tests with an appropriate commanded RAAT test outcome. An appropriate RAAT outcome consists of either a device-determined threshold or a code indicating that a threshold could not be determined and representing a condition that is beyond the control of the RAAT feature and could occur as well in manual threshold test, such as atrial fibrillation.
Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin	3 months post implant	This outcome measure was analyzed only for the combined population (Pacemaker and CRT-P). The sufficient pacing output voltage that is able to capture the right atrium was evaluated by the proportion of Right Atrial Automatic Threshold (RAAT) tests with \[RAAToutput ≥ (max(BP,UP) + δ )\] where BP refers to the manual bipolar threshold, UP refers to the manual unipolar threshold, and δ refers to the safety margin of 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the commanded threshold and the maximum manual threshold (i.e. the maximum of the manual unipolar and manual bipolar thresholds) obtained at a visit.

Trial Locations

Locations (21): Wilhelminenspital
🇦🇹
Vienna, Austria
Landesklinikum Wiener Neustadt
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Wiener Neustadt, Austria
Clinique Universitaires Saint Luc
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Brussels, Belgium
Rigshospitalet Copenhagen
🇩🇰
Copenhagen, Denmark
Gentofte University Hospital
🇩🇰
Hellerup, Denmark
NCN Nouvelles Cliniques Nantaises
🇫🇷
Nantes Cedex 2, France
Clinique Saint-Hilaire Rouen
🇫🇷
Rouen, France
Krankenhaus Neu Bethlehem
🇩🇪
Göttingen, Germany
Heinrich Braun Krankenhaus
🇩🇪
Zwickau, Germany
Prince of Wales Hospital
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Shatin, New Territories, Hong Kong
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Wilhelminenspital
🇦🇹Vienna, Austria