Clinical trial NCT01441583: Ingenio Device Algorithm Study
Official title: Ingenio Device Algorithm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Node Disease
AV Block
Heart Failure
Keywords: pacemaker, CRT-P, auto threshold
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
timeFrame: 3 months post implant
measure: System-related Complication-free Rate
timeFrame: 90 days post-implant
Secondary outcomes:
measure: Accuracy of Ambulatory RAAT
timeFrame: 3 months post-implant
measure: Appropriate RAAT Test Outcome
timeFrame: 3 months post-implant
measure: 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
timeFrame: 3 months post implant
measure: Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin
timeFrame: 3 months post implant
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Brussels
country: Belgium
facility: Clinique Universitaires Saint Luc
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
city: Nantes Cedex 2
country: France
facility: NCN Nouvelles Cliniques Nantaises
city: Rouen
country: France
facility: Clinique Saint-Hilaire Rouen
city: Göttingen
country: Germany
facility: Krankenhaus Neu Bethlehem
city: Zwickau
country: Germany
facility: Heinrich Braun Krankenhaus
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini Policlinico Universitario
state: CZ
city: Roma
country: Italy
facility: Policlinico Casilino
state: RM
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Golden Jubilee National Hospital
name: Roy S Gardner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Jens Goetzke, Dipl.-Ing. (FH)
role: STUDY_DIRECTOR
References: