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The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| CRT-P | Experimental | CRT-P devices were not involved in RYTHMIQ endpoint evaluation, only RAAT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAAT | Device | For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy S Gardner, MD | Golden Jubilee National Hospital | Principal Investigator |
| Jens Goetzke, Dipl.-Ing. (FH) | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelminenspital | Vienna | 1160 | Austria | |||
| Landesklinikum Wiener Neustadt |
Of 139 subjects, 132 were implanted with a study device. Of those subjects who were not implanted with a study device 4 signed informed consent, met eligibility criteria and had anesthesia administered in preparation for the surgical procedure but did not receive a study device (classified as 'Attempt') and 3 signed the informed consent, met eligibility criteria but did not undergo an implant (classified as an 'Intent').
Subjects were recruited from the general patient population indicated for a dual chamber pacemaker or cardiac resynchronization therapy pacemaker implantation at 15 study centers. First enrollment date was in October 2011 and the last subject was enrolled in March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | RYTHMIQ Off at Pre-discharge, On at 1-Month | Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month |
| FG001 | RYTHMIQ On at Pre-Discharge, Off at 1-Month | Pacemaker -RYTHMIQ On at Pre-Discharge, Off at 1-Month |
| FG002 | CRT-P | All CRT-P implanted subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis Population includes all implanted subjects (n=132) as well as 4 attempted CRT-P subjects that could not be successfully implanted but underwent anesthesia. Total baseline population is therefore n=136.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pacemaker | Subjects receiving a pacemaker study device (implanted or attempted) |
| BG001 | CRT-P | Subjects receiving a CRT-P study device (implanted or attempted) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. Analysis performed on subjects with paired datasets, each consisting of a commanded RAAT threshold and manual unipolar threshold collected at the 1- and 3-month visits. | Posted | Number | 95% Confidence Interval | percentage of accurate RAAT tests | 3 months post implant | Paired threshold tests | Paired threshold tests |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Implanted With a Study Device or Attempted to be Implanted With a Study Device | The study's primary endpoints were designed to assess adverse events for all participants under one category of Cardiac Implantable Electronic Devices (CIED) safety as a unified group. Reporting thus reflects the collective safety profile of CIED interventions as planned and analyzed. This approach was consistent with the study's protocol and objectives, which did not include arm/group-specific AE analysis as a key outcome. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PG - Oversensing - RV | Product Issues | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extracardiac stimulation - LV | Product Issues | Systematic Assessment | Extracardiac stimulation - LV, only applicable to LV leads. CRT-P subjects have LV leads implanted, Pacemaker subjects do not have LV leads implanted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Boston Scientific | +18002273422 | jens.goetzke@bsci.com |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D054537 | Atrioventricular Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| RYTHMIQ | Device | For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment |
|
| 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. | 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. | 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. | 3 months post implant |
| Wiener Neustadt |
| 2700 |
| Austria |
| Clinique Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Rigshospitalet Copenhagen | Copenhagen | 2100 | Denmark |
| Gentofte University Hospital | Hellerup | 2900 | Denmark |
| NCN Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Clinique Saint-Hilaire Rouen | Rouen | 7600 | France |
| Krankenhaus Neu Bethlehem | Göttingen | 37073 | Germany |
| Heinrich Braun Krankenhaus | Zwickau | 08060 | Germany |
| Prince of Wales Hospital | Shatin | New Territories | Hong Kong |
| Azienda Ospedaliera Mater Domini Policlinico Universitario | Catanzaro | CZ | 88100 | Italy |
| Policlinico Casilino | Roma | RM | 00169 | Italy |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Amphia Ziekenhuis | Breda | 4818 CK | Netherlands |
| Rijnland Ziekenhuis | Leiderdorp | 2353 GA | Netherlands |
| Hospital Clinico Y Provincial | Barcelona | 08036 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Karolinska Hospital | Stockholm | 17176 | Sweden |
| Golden Jubilee National Hospital | Clydebank | G81 4HX | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| Underwent anaesthesia, but not finally implanted |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pacemaker Indication | Not applicable for CRT-P device category | Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed. | Count of Participants | Participants |
|
| CRT-P Indication | Class I indication (ind.) for CRT-P device, defined by Left Ventricular Ejection Fraction (EF) = ≤ 35%, sinus rhythm, NYHA Class III, or ambulatory NYHA Class IV, QRS width (QRS) of ≥ 120 ms and optimal heart failure drug therapy (OPT). Recommended ind. Class IIa, defined by EF ≤ 35%, NYHA Class III, or ambulatory NYHA Class IV, OPT, frequent dependence on ventricular pacing. Ind. should be considered. Class IIb, defined by EF ≤ 35%, NYHA Class I or II, OPT, device implant with anticipated frequent ventricular pacing. Ind. can be considered. Not applicable for pacemaker device category. | CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed. | Count of Participants | Participants |
|
| NYHA Class | New York Heart Association (NYHA) Classification places subjects into one of four categories based on their physical activity limitations with Class I = no limitations, Class II = Mild limitations, Class III = Moderate limitations and Class IV = Severe limitations. | Count of Participants | Participants |
|
| LVEF | Measure not reported for all subjects. | Mean | Standard Deviation | percent |
|
| QRS Duration | Measure not reported for all subjects. | Mean | Standard Deviation | ms |
|
| BMI | Measure not reported for all subjects. | Mean | Standard Deviation | kg/m^2 |
|
| Body Surface Area | Measure not reported for all subjects. | Mean | Standard Deviation | m^2 |
|
| Concomitant Medications | Subjects may contribute to more than one category. | Count of Participants | Participants |
|
| Etiology | Count of Participants | Participants |
|
| Atrial Arrhythmias | Subjects may contribute to more than one category | Count of Participants | Participants |
|
| Brady Arrhythmias: | Subjects may contribute to more than one category | Count of Participants | Participants |
|
| Cardiac Disease & Arrhythmia HistorY | Subjects may contribute to more than one category | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | RAAT Commanded Threshold | Subjects with paired RAAT commanded threshold and manual unipolar threshold available |
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage of subjects free from SRC | 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. | Posted | Number | 95% Confidence Interval | Paired threshold tests | 3 months post-implant | Paired threshold tests | Paired threshold tests |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage of approprite RAAT tests | 3 months post-implant | threshold tests | threshold tests |
|
|
|
| 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. | Pacemaker subjects with RYTHMIQ information available for both randomization periods. | Posted | Median | Full Range | Percentage of RV pacing | 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) + 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. | Pooled subjects with a sufficient pacing output voltage to capture the right atrium at the 1-month and the 3-month follow-up visits. | Posted | Number | 95% Confidence Interval | Percentage of RAAT w. sufficient output | 3 months post implant | Right Atrial Automatic Threshold Tests | Right Atrial Automatic Threshold Tests |
|
|
|
| 5 |
| 136 |
| 52 |
| 136 |
| 24 |
| 136 |
| PG - Infection (> 30 days post-implant) | Product Issues | Systematic Assessment |
|
| Procedure - Venous occlusion | Vascular disorders | Systematic Assessment |
|
| Hematoma - Pocket (<=30 days post-implant) | Vascular disorders | Systematic Assessment |
|
| Renal failure due to contrast media - Procedure | Renal and urinary disorders | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | Systematic Assessment |
|
| Venous occlusion | Product Issues | Systematic Assessment |
|
| LV - difficult visualization | Vascular disorders | Systematic Assessment |
|
| Dislodgment - RA | Product Issues | Systematic Assessment |
|
| Dislodgment - RV | Product Issues | Systematic Assessment |
|
| Extracardiac stimulation - LV | Product Issues | Systematic Assessment |
|
| Dyspnea - Heart failure | Cardiac disorders | Systematic Assessment |
|
| Heart failure symptoms - Unspecified | Cardiac disorders | Systematic Assessment |
|
| Multiple heart failure symptoms | Cardiac disorders | Systematic Assessment |
|
| Atrial Arrhythmias (Heart Failure related) | Cardiac disorders | Systematic Assessment |
|
| Pleural Effusion | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation (AF) | Cardiac disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Other SVT | Cardiac disorders | Systematic Assessment | AVRT, AVNRT, EAT etc. |
|
| Peripheral vascular disease | Vascular disorders | Systematic Assessment |
|
| Intermittent claudication | Cardiac disorders | Systematic Assessment |
|
| Aortic regurgitation | Vascular disorders | Systematic Assessment |
|
| Syncope | Cardiac disorders | Systematic Assessment |
|
| Dizziness | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Cerebrovascular accident (CVA) | Cardiac disorders | Systematic Assessment |
|
| Pulmonary embolism | Cardiac disorders | Systematic Assessment |
|
| Adverse Drug Effect | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Multiple symptoms | General disorders | Systematic Assessment |
|
| Death | Product Issues | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Systemic infection | Infections and infestations | Systematic Assessment |
|
| Physical trauma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
|
| Renal | Renal and urinary disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Integumentary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
|
| Immune | Immune system disorders | Systematic Assessment |
|
| Cancer | General disorders | Systematic Assessment |
|
| Multi-system failure | General disorders | Systematic Assessment |
|
|
| Atrial fibrillation (AF) | Cardiac disorders | Systematic Assessment |
|
Consultant (PI) acknowledges and agrees that (i) Consultant shall not publish any data, report, white papers or other materials arising out of the Services performed pursuant to this Agreement without the prior written consent of Boston Scientific, and (ii) any such publication shall not include Boston Scientific Confidential Information except prior written consent of Boston Scientific.
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |