Ingenio Device Algorithm Study (IVORY)

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; AV Block; Sinus Node Disease
• Intervention / Treatment: Device: RAAT; Device: RYTHMIQ

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

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Wilhelminenspital
  • Wiener Neustadt, Austria, 2700
    • Landesklinikum Wiener Neustadt
• Belgium
  • Brussels, Belgium, 1200
    • Clinique Universitaires Saint Luc
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhagen
  • Hellerup, Denmark, 2900
    • Gentofte University Hospital
• France
  • Nantes Cedex 2, France, 44277
    • NCN Nouvelles Cliniques Nantaises
  • Rouen, France, 7600
    • Clinique Saint-Hilaire Rouen
• Germany
  • Göttingen, Germany, 37073
    • Krankenhaus Neu Bethlehem
  • Zwickau, Germany, 08060
    • Heinrich Braun Krankenhaus
• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Prince of Wales Hospital
• Italy
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Azienda Ospedaliera Mater Domini Policlinico Universitario
  • RM
    • Roma, RM, Italy, 00169
      • Policlinico Casilino
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia ziekenhuis
  • Leiderdorp, Netherlands, 2353 GA
    • Rijnland Ziekenhuis
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinico Y Provincial
  • Pamplona, Spain, 31008
    • Clinica Universitaria de Navarra
• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital
  • Stockholm, Sweden, 17176
    • Karolinska hospital
• United Kingdom
  • Clydebank, United Kingdom, G81 4HX
    • Golden Jubilee National Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Northern General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month; 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; For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT); Device: RYTHMIQ; For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
Active Comparator: Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month; 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; For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT); Device: RYTHMIQ; For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
Experimental: CRT-P; CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT.	Device: RAAT; For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)	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.	3 months post implant
System-related Complication-free Rate	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.	90 days post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Ambulatory RAAT	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.	3 months post-implant
Appropriate RAAT Test Outcome	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.	3 months post-implant
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	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.	3 months post implant
Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin	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.	3 months post implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Roy S Gardner, MD, Golden Jubilee National Hospital; Study Director: Jens Goetzke, Dipl.-Ing. (FH), Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimated): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pacemaker, CRT-P, auto threshold
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Sick Sinus Syndrome
• Other Study ID Numbers: CR-CL-07202011-B-H