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Ingenio Device Algorithm Study (IVORY)

Primary Purpose

Sinus Node Disease, AV Block, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RAAT
RYTHMIQ
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Node Disease focused on measuring pacemaker, CRT-P, auto threshold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wilhelminenspital
  • Landesklinikum Wiener Neustadt
  • Clinique Universitaires Saint Luc
  • Rigshospitalet Copenhagen
  • Gentofte University Hospital
  • NCN Nouvelles Cliniques Nantaises
  • Clinique Saint-Hilaire Rouen
  • Krankenhaus Neu Bethlehem
  • Heinrich Braun Krankenhaus
  • Prince of Wales Hospital
  • Azienda Ospedaliera Mater Domini Policlinico Universitario
  • Policlinico Casilino
  • Institut Jantung Negara
  • Amphia Ziekenhuis
  • Rijnland Ziekenhuis
  • Hospital Clinico Y Provincial
  • Clinica Universitaria de Navarra
  • Sahlgrenska University Hospital
  • Karolinska Hospital
  • Golden Jubilee National Hospital
  • Northern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
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

Secondary Outcome Measures

Accuracy of Ambulatory Right Atrial Automatic Threshold
Appropriate RAAT Test Outcome
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.
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

Full Information

First Posted
September 26, 2011
Last Updated
July 16, 2013
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01441583
Brief Title
Ingenio Device Algorithm Study
Acronym
IVORY
Official Title
Ingenio Device Algorithm Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Disease, AV Block, Heart Failure
Keywords
pacemaker, CRT-P, auto threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RYTHMIQ Off at Pre-discharge, On at 1-Month
Arm Type
Active Comparator
Arm 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.
Arm Title
RYTHMIQ On at Pre-Discharge, Off at 1-Month
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
RAAT
Intervention Description
For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)
Intervention Type
Device
Intervention Name(s)
RYTHMIQ
Intervention Description
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
Primary Outcome Measure Information:
Title
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
Time Frame
3 months post implant
Title
System-related Complication-free rate
Description
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
Time Frame
90 days post-implant
Secondary Outcome Measure Information:
Title
Accuracy of Ambulatory Right Atrial Automatic Threshold
Time Frame
3 months post-implant
Title
Appropriate RAAT Test Outcome
Time Frame
3 months post-implant
Title
RYTHMIQ
Description
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.
Time Frame
3 months post implant
Title
RAAT Pace Output Margin
Description
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
Time Frame
3 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy S Gardner, MD
Organizational Affiliation
Golden Jubilee National Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Goetzke, Dipl.-Ing. (FH)
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Landesklinikum Wiener Neustadt
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
Clinique Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Rigshospitalet Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
NCN Nouvelles Cliniques Nantaises
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Clinique Saint-Hilaire Rouen
City
Rouen
ZIP/Postal Code
7600
Country
France
Facility Name
Krankenhaus Neu Bethlehem
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Heinrich Braun Krankenhaus
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Azienda Ospedaliera Mater Domini Policlinico Universitario
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Policlinico Casilino
City
Roma
State/Province
RM
ZIP/Postal Code
00169
Country
Italy
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Rijnland Ziekenhuis
City
Leiderdorp
ZIP/Postal Code
2353 GA
Country
Netherlands
Facility Name
Hospital Clinico Y Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Golden Jubilee National Hospital
City
Clydebank
ZIP/Postal Code
G81 4HX
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

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Ingenio Device Algorithm Study

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