Ingenio Device Algorithm Study

NCT01441583 | Completed Results

• 1 other identifier: CR-CL-07202011-B-H
• Study Type: interventional
• Target: 139
• Locations: 12 countries
• Sites: 21

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.

Conditions

Sinus Node Disease; AV Block; Heart Failure

Keywords

pacemaker, CRT-P, auto threshold

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Accuracy of Ambulatory RAAT

  3 months post-implant

• Appropriate RAAT Test Outcome

  3 months post-implant

• 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

  3 months post implant

• Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin

  3 months post implant

Study Arms (3)

Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month

ACTIVE COMPARATOR

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; Device: RYTHMIQ

Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month

ACTIVE COMPARATOR

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; Device: RYTHMIQ

CRT-P

EXPERIMENTAL

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

Device: RAAT

Interventions

RAAT DEVICE

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

CRT-P; Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month; Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month

RYTHMIQ DEVICE

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

Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month; Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (21)

Wilhelminenspital

Vienna, 1160, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Clinique Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

NCN Nouvelles Cliniques Nantaises

Nantes, 44277, France

Location

Clinique Saint-Hilaire Rouen

Rouen, 7600, France

Location

Krankenhaus Neu Bethlehem

Göttingen, 37073, Germany

Location

Heinrich Braun Krankenhaus

Zwickau, 08060, Germany

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Azienda Ospedaliera Mater Domini Policlinico Universitario

Catanzaro, CZ, 88100, Italy

Location

Policlinico Casilino

Roma, RM, 00169, Italy

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, 2353 GA, Netherlands

Location

Hospital Clinico Y Provincial

Barcelona, 08036, Spain

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Karolinska Hospital

Stockholm, 17176, Sweden

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

jens.goetzke@bsci.com

+18002273422

Study Officials

• Roy S Gardner, MD

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

• Jens Goetzke, Dipl.-Ing. (FH)

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 27, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Locations

DK (2); FR (2); SE (2); ES (2); IT (2); BE (1); DE (2); GB (2); MY (1); AU (2); NL (2); HK (1)