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Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AV Therapy Assessment group | Experimental | appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV Therapy Assessment-B301 investigational device | Device | Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate Shock Free Rate | Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks. | Three months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion Success Rate up to Three Months Post-implant | For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery. |
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Inclusion Criteria:
Exclusion Criteria:
* None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | United States | |||
| Northern California Heart Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | B301 Device | B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Three months post-implant |
| Larkspur |
| California |
| United States |
| Orlando Regional Hospital | Orlando | Florida | United States |
| Heart and Vascular Institute | St. Petersburg | Florida | United States |
| Piedmont Hospital | Atlanta | Georgia | United States |
| St. Joseph Hospital | Savannah | Georgia | United States |
| Good Samaritan Hospital | Downers Grove | Illinois | United States |
| Heart Care Research Foundation | Merrionette Park | Illinois | United States |
| St. Mary Medical Center | Hobart | Indiana | United States |
| Mercy Hospital Medical Center | Des Moines | Iowa | United States |
| Central Baptist Hospital | Lexington | Kentucky | United States |
| Louisville Cardiology Medical Group | Louisville | Kentucky | United States |
| Medical Center Cardiologist Research | Louisville | Kentucky | United States |
| Owensboro Mercy Health System | Owensboro | Kentucky | United States |
| Ochsner Foundation Hospital | New Orleans | Louisiana | United States |
| Boston Medical Center | Boston | Massachusetts | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | United States |
| Baystate Medical Center | Springfield | Massachusetts | United States |
| University of Massachusetts | Worcester | Massachusetts | United States |
| Henry Ford Hospital | Detroit | Michigan | United States |
| Saint Mary's Duluth Clinic | Duluth | Minnesota | United States |
| St. Anthony's Medical Center | St Louis | Missouri | United States |
| Sunrise Hospital & Medical Center | Las Vegas | Nevada | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | United States |
| Mount Sinai Medical Center | New York | New York | United States |
| Christ Hospital - Cincinnati | Cincinnati | Ohio | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | United States |
| Ohio State University Medical Center | Columbus | Ohio | United States |
| Hillcrest Medical Center | Tulsa | Oklahoma | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | United States |
| Baylor University Medical Center | Dallas | Texas | United States |
| Center For Cardiac Arrhythmias | Houston | Texas | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | United States |
| Chippenham Medical Center | Richmond | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AV Therapy Assessment Group | AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS) AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device Ventricular tachyarrhythmia rescue shock feature AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Inappropriate Shock Free Rate | Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks. | Posted | Number | % of shock free rates | Three months post-implant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Conversion Success Rate up to Three Months Post-implant | For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery. | Posted | Number | % of conversion rates | Three months post-implant |
|
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Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit).
An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
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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 | B301 Device | B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device | 4 | 211 | 52 | 211 | 17 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse reaction - General | General disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
| |
| Aortic stenosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Dislodgment - Elevated threshold - RV | Cardiac disorders | Systematic Assessment |
| ||
| Dislodgment - Unable to capture - RA | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea - Heart failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Early ERI - Random component failure | Cardiac disorders | Systematic Assessment |
| ||
| Endocrine | Endocrine disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Extracardiac stimulation - RV | Cardiac disorders | Systematic Assessment |
| ||
| Genitourinary | Reproductive system and breast disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Guidewire removal- femoral vein | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Head, eyes, ears, nose, throat (HEENT) | Eye disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Hematological | Blood and lymphatic system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Hematoma - Pocket (<=30 days post-implant) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Inappropriate tachy therapy - SVT | Cardiac disorders | Systematic Assessment |
| ||
| Integumentary | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Intermittent claudication | Cardiac disorders | Systematic Assessment |
| ||
| Latching | General disorders | Systematic Assessment |
| ||
| Migration | General disorders | Systematic Assessment |
| ||
| Multiple heart failure symptoms | Cardiac disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Multiple symptoms | General disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Multi-system failure - Heart failure | Cardiac disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Peripheral edema - Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Pulmonary edema - Heart failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. |
| |
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| Renal insufficiency - Heart failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Seroma - Pocket (<=30 days post-implant) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elke Sommerijns | Boston Scientific | +32 479 76 71 56 | elke.sommerijns@bsci.com |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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