Ingenio Device Algorithm Study (IVORY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01441583
First received: September 26, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Sinus Node Disease
AV Block
Heart Failure
Device: RAAT
Device: RYTHMIQ

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ingenio Device Algorithm Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Accuracy of Commanded Right Atrial Automatic Threshold (RAAT) [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
  • System-related Complication-free rate [ Time Frame: 90 days post-implant ] [ Designated as safety issue: Yes ]
    • 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 [ Time Frame: 3 months post-implant ] [ Designated as safety issue: No ]
  • Appropriate RAAT Test Outcome [ Time Frame: 3 months post-implant ] [ Designated as safety issue: No ]
  • RYTHMIQ [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months post implant ] [ Designated as safety issue: Yes ]
    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


Enrollment: 139
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
Other Name: RAAT
Device: RYTHMIQ
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
Other Name: RYTHMIQ
Active Comparator: 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)
Other Name: RAAT
Device: RYTHMIQ
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441583

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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01441583     History of Changes
Other Study ID Numbers: CR-CL-07202011-B-H
Study First Received: September 26, 2011
Last Updated: July 16, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Ethics Committee
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Ethics Committee
Italy: Ministry of Health
Malaysia: Institutional Review Board
Netherlands: Independent Ethics Committee
Spain: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:
pacemaker, CRT-P, auto threshold

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014