Sinus Node DiseaseIVORYNCT01441583
Ingenio Device Algorithm Study
A study testing RAAT and RYTHMIQ in people with Sinus Node Disease and AV Block, run by Boston Scientific Corporation at 21 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Disease, AV Block, Heart Failure
- What is being tested?
- RAAT and RYTHMIQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 21 sitesin 12 countries
- Study dates
- Oct 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 12 countries.
21 sites in 12 countries
Austria2 sites
Wilhelminenspital
Vienna, 1160
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700
Denmark2 sites
Rigshospitalet Copenhagen
Copenhagen, 2100
Gentofte University Hospital
Hellerup, 2900
France2 sites
NCN Nouvelles Cliniques Nantaises
Nantes, 44277
Clinique Saint-Hilaire Rouen
Rouen, 7600
Germany2 sites
Krankenhaus Neu Bethlehem
Göttingen, 37073
Heinrich Braun Krankenhaus
Zwickau, 08060
Italy2 sites
Azienda Ospedaliera Mater Domini Policlinico Universitario
Catanzaro, CZ, 88100
Policlinico Casilino
Roma, RM, 00169
Netherlands2 sites
Amphia Ziekenhuis
Breda, 4818 CK
Rijnland Ziekenhuis
Leiderdorp, 2353 GA
Spain2 sites
Hospital Clinico Y Provincial
Barcelona, 08036
Clinica Universitaria de Navarra
Pamplona, 31008
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Karolinska Hospital
Stockholm, 17176
United Kingdom2 sites
Golden Jubilee National Hospital
Clydebank, G81 4HX
Northern General Hospital
Sheffield, S5 7AU
About this study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Read the 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
- Being tested
- RAAT, RYTHMIQ
- Keywords
- pacemaker, CRT-P, auto threshold
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAATDevice
For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)
RYTHMIQDevice
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: RAAT; Device: RYTHMIQ |
| CRT-P | Experimental | CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT. Receives: Device: RAAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days post-implant
Secondary outcomes (4)
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.
Measured: 3 months post-implant
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.
Measured: 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
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.
Measured: 3 months post implant
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) + δ )] where BP refers to the manual bipolar threshold, UP refers to the manual unipolar threshold, and δ 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.
Measured: 3 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sinus Node DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy S Gardner, MD, Principal investigator, Golden Jubilee National HospitalJens Goetzke, Dipl.-Ing. (FH), Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441583
- Sponsor's protocol ID
- CR-CL-07202011-B-H
- Acronym
- IVORY
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2011
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingenio Device Algorithm Study
- ClinicalTrials.gov ID
- NCT01441583
- Acronym / sponsor ID
- IVORY / CR-CL-07202011-B-H
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Keywords
- pacemaker, CRT-P, auto threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month | Active comparator | Device: RAAT, Device: RYTHMIQFor 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. |
| Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month | Active comparator | Device: RAAT, Device: RYTHMIQFor 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. |
| CRT-P | Experimental | Device: RAATCRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAATFor Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT) | Device | CRT-P, Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month, Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month |
| RYTHMIQFor pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment | Device | Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month, Pacemaker - RYTHMIQ On at Pre-Discharge, Off at 1-Month |
Primary outcome
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
Time frame: 3 months post implant
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.
System-related Complication-free Rate
Time frame: 90 days post-implant
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.
4 secondary outcomes
Accuracy of Ambulatory RAAT
Time frame: 3 months post-implant
Appropriate RAAT Test Outcome
Time frame: 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
Time frame: 3 months post implant
Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin
Time frame: 3 months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy S Gardner, MD principal investigator
Golden Jubilee National Hospital
Jens Goetzke, Dipl.-Ing. (FH) study director
Boston Scientific Corporation
21 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAAT and RYTHMIQ in people with Sinus Node Disease and AV Block, run by Boston Scientific Corporation at 21 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Austria, Denmark, France, Germany, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT) (time frame: 3 months post implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.