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Existing trials demonstrate reduction in fluoroscopy with MediGuide
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The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:
Additionally, this study will address the following
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT | Patients who are undergoing CRT implantation utilizing MediGuide system and tools |
| |
| EP | Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT implantation | Procedure | It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Fluoroscopy Time | Amount of fluoroscopy time during CRT implant or EP procedure | Expected time frame is day 1 of the study |
| Periprocedural Adverse Event | Adverse event until patients are discharged from the site center | From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads
EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John C Lincoln North Mountain Hospital | Phoenix | Arizona | 85020 | United States | ||
| Athens Regional Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | CRT Group | All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads. |
| FG001 | EP Group | All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CRT Group | All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads. |
| 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 | Amount of Fluoroscopy Time | Amount of fluoroscopy time during CRT implant or EP procedure | Posted | Mean | Standard Deviation | MINUTES | Expected time frame is day 1 of the study |
|
The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
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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 | CRT Group | All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhyrhmia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Ruffner, Clinical Program Director | Abbott | +1 651 756 6717 | Kristin.Ruffner@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2015 | Jan 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| MediGuide | Device |
|
| EP | Procedure |
|
| Athens |
| Georgia |
| 30606 |
| United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30046 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| North Texas Heart Center | Dallas | Texas | 75231 | United States |
| Memorial Hermann Southwest Hospital | Houston | Texas | United States |
| St. Andrews War Memorial Hospital | East Brisbane | Australia |
| A. ö. Krankenhaus der Elisabethinen Linz | Linz | Austria |
| Institut de Cardiologie de Montreal | Montreal | Canada |
| Tartu University Hospital | Tartu | Estonia |
| Klinikum Inglostadt | Ingolstadt | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Deutsches Herzzentrum München des Freistaates Bayern | München | Germany |
| Kliniken Villingen-Schwenningen | Villingen-Schwenningen | Germany |
| Leiden University Medical Center | Leiden | Netherlands |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| BG001 |
| EP Group |
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA classification | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain. NYHA I: - No symptoms and no limitation in ordinary physical activity NYHA II: Mild symptoms / slight limitation during ordinary activity. NYHA III: Marked limitation in activity due to symptoms NYHA IV: Severe limitations, even while at rest. | Count of Participants | Participants |
|
| LEFT VENTRICULAR EJECTION FRACTION | Mean | Standard Deviation | PERCENTAGE |
|
|
|
| Primary | Periprocedural Adverse Event | Adverse event until patients are discharged from the site center | Posted | Number | ADVERSE EVENTS | From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days |
|
|
|
| 0 |
| 142 |
| 5 |
| 142 |
| 0 |
| 142 |
| EG001 | EP Group | All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry. | 0 | 419 | 12 | 419 | 11 | 11 |
| Bleeding (non-hematoma) | Vascular disorders | Non-systematic Assessment |
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| Cardiac Perforation | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Coronary Sinus Perforation | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Phrenic Nerve/Diaphragmatic Stimulation | Nervous system disorders | Non-systematic Assessment |
|
| Pseudoaneurysm | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Syncope Unknown Etiology | General disorders | Non-systematic Assessment |
|
| OTHER | General disorders | Non-systematic Assessment |
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| Bleeding(Non-Hematoma) | Vascular disorders | Non-systematic Assessment |
|
| Chest Pain/Discomfort | Cardiac disorders | Non-systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| New Or Worsened Angina | Cardiac disorders | Non-systematic Assessment |
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| Pericarditis | Infections and infestations | Non-systematic Assessment |
|
| Pseudoaneurysm | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thromboembolism | Vascular disorders | Non-systematic Assessment |
|
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| NYHA III |
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| NYHA IV |
|
| NOT AVAILABLE |
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