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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01441583
Other study ID # CR-CL-07202011-B-H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date April 2013

Study information

Verified date March 2024
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date April 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
RAAT
For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)
RYTHMIQ
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment

Locations

Country Name City State
Austria Wilhelminenspital Vienna
Austria Landesklinikum Wiener Neustadt Wiener Neustadt
Belgium Clinique Universitaires Saint Luc Brussels
Denmark Rigshospitalet Copenhagen Copenhagen
Denmark Gentofte University Hospital Hellerup
France NCN Nouvelles Cliniques Nantaises Nantes Cedex 2
France Clinique Saint-Hilaire Rouen Rouen
Germany Krankenhaus Neu Bethlehem Göttingen
Germany Heinrich Braun Krankenhaus Zwickau
Hong Kong Prince of Wales Hospital Shatin New Territories
Italy Azienda Ospedaliera Mater Domini Policlinico Universitario Catanzaro CZ
Italy Policlinico Casilino Roma RM
Malaysia Institut Jantung Negara Kuala Lumpur
Netherlands Amphia Ziekenhuis Breda
Netherlands Rijnland Ziekenhuis Leiderdorp
Spain Hospital Clinico Y Provincial Barcelona
Spain Clinica Universitaria de Navarra Pamplona
Sweden Sahlgrenska University Hospital Göteborg
Sweden Karolinska Hospital Stockholm
United Kingdom Golden Jubilee National Hospital Clydebank
United Kingdom Northern General Hospital Sheffield

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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) + d )] where BP refers to the manual bipolar threshold, UP refers to the manual unipolar threshold, and d 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
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