Ingenio Device Algorithm Study

NCT ID: NCT01441583

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-04-30

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

Conditions

Sinus Node Disease; AV Block; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

RAAT

Intervention Type: DEVICE

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

RYTHMIQ

Intervention Type: DEVICE

For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

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.

Group Type: ACTIVE_COMPARATOR

RAAT

Intervention Type: DEVICE

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

RYTHMIQ

Intervention Type: DEVICE

For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

CRT-P

CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT.

Group Type: EXPERIMENTAL

RAAT

Intervention Type: DEVICE

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

Interventions

RAAT

For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)

Intervention Type: DEVICE

RYTHMIQ

For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy S Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

Golden Jubilee National Hospital

Jens Goetzke, Dipl.-Ing. (FH)

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Wilhelminenspital

Vienna, , Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, , Austria

Clinique Universitaires Saint Luc

Brussels, , Belgium

Rigshospitalet Copenhagen

Copenhagen, , Denmark

Gentofte University Hospital

Hellerup, , Denmark

NCN Nouvelles Cliniques Nantaises

Nantes, , France

Clinique Saint-Hilaire Rouen

Rouen, , France

Krankenhaus Neu Bethlehem

Göttingen, , Germany

Heinrich Braun Krankenhaus

Zwickau, , Germany

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Azienda Ospedaliera Mater Domini Policlinico Universitario

Catanzaro, CZ, Italy

Policlinico Casilino

Roma, RM, Italy

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Amphia Ziekenhuis

Breda, , Netherlands

Rijnland Ziekenhuis

Leiderdorp, , Netherlands

Hospital Clinico Y Provincial

Barcelona, , Spain

Clinica Universitaria de Navarra

Pamplona, , Spain

Sahlgrenska University Hospital

Gothenburg, , Sweden

Karolinska Hospital

Stockholm, , Sweden

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Countries

Austria; Belgium; Denmark; France; Germany; Hong Kong; Italy; Malaysia; Netherlands; Spain; Sweden; United Kingdom

Other Identifiers

CR-CL-07202011-B-H

Identifier Type: -

Identifier Source: org_study_id