Ingenio Device Algorithm Study

Heart Failure Clinical Trial

— IVORY  

Official title:

Ingenio Device Algorithm Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441583
• Other study ID #: CR-CL-07202011-B-H
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• AV Block
• Heart Failure
• Sick Sinus Syndrome
• Sinus Node Disease

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