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Early termination was granted by FDA based on study results meeting the post approval requirements.
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The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implants | Patients successfully implanted with the ACUITY Spiral Lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUITY Spiral Left Ventricular Lead | Device | The implant of the ACUITY Spiral Lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Left Ventricular Lead-related Complication Free Rate | Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be a broad base representative of those recieving the ACUITY Spiral lead.
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Hedrich, MD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heart Clinic | Birmingham | Alabama | 35235 | United States | ||
| University of Alabama at Birmingham |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implants | Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2012 | Jul 10, 2018 |
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| Birmingham |
| Alabama |
| 35294 |
| United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Tri-City Cardiology | Mesa | Arizona | 85206 | United States |
| Arizona Arrhythmia Research Center | Scottsdale | Arizona | 85258 | United States |
| Pima Heart Physicians | Tucson | Arizona | 85712 | United States |
| Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | 72401 | United States |
| Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | United States |
| Comprehensive Cardiovascular Medical Group | Bakersfield | California | 93309 | United States |
| Belott Cardiology | El Cajon | California | 92021 | United States |
| Fullerton Cardiovascular | Fullerton | California | 92835 | United States |
| Cardiac Device Rhythm Specialists | Los Angeles | California | 90033 | United States |
| Cedars - Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Memorial Hospital | Modesto | California | 95355 | United States |
| Cardiac Rhythm Specialists, Inc. | Northridge | California | 91325 | United States |
| Cardiovascular Consultants | Oakland | California | 94609 | United States |
| Orange County Heart Institute | Orange | California | 92868 | United States |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States |
| Truong D Duong Cardiac Electrophysiology | Riverside | California | 92501 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| Sansum Clinic | Santa Barbara | California | 93102 | United States |
| Bethesda Memorial Hospital | Atlantis | Florida | 33462 | United States |
| Heart and Vascular Institute of Florida | Clearwater | Florida | 33756 | United States |
| Miami International Cardiology Consultants | Miami | Florida | 33137 | United States |
| Complete Cardiology Care | New Smyrna Beach | Florida | 32168 | United States |
| Orlando Regional Hospital | Orlando | Florida | 32806 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| West Coast Arrhythmia Center | Trinity | Florida | 34655 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| Medical College of Georgia Health | Augusta | Georgia | 30912 | United States |
| Northeast Georgia Heart Center | Gainesville | Georgia | 30501 | United States |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | United States |
| St Lukes Idaho Cardiology Assoc. | Boise | Idaho | 83712 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Heart Care Research Foundation | Mokena | Illinois | 60448 | United States |
| Northern Indiana Research Alliance | Fort Wayne | Indiana | 46804 | United States |
| St. Mary Medical Center - Indiana | Hobart | Indiana | 46342 | United States |
| Via-Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Southern Kentucky Heart Institute | Bowling Green | Kentucky | 42101 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| St. Joseph Hospital | Lexington | Kentucky | 40504 | United States |
| Commonwealth Cardiology | Louisville | Kentucky | 40202 | United States |
| Baltimore Heart Association | Randallstown | Maryland | 21133 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Steward St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Heart Care | Detroit | Michigan | 48201 | United States |
| Cardiology Consultants of East Michigan | Flint | Michigan | 48507 | United States |
| West Michigan Heart | Grand Rapids | Michigan | 49301 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| St. Mary's Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| Missouri Heart Center | Columbia | Missouri | 65201 | United States |
| Research Medical Center | Kansas City | Missouri | 64114 | United States |
| Cox Health | Springfield | Missouri | 65807 | United States |
| Metro Heart Group South County | St Louis | Missouri | 63128 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| New Jersey Cardiology Associates | West Orange | New Jersey | 07052 | United States |
| Capital Cardiology Associates | Albany | New York | 12208 | United States |
| Island Cardiac Specialists | Garden City | New York | 11530 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Mid-Carolina Cardiology | Charlotte | North Carolina | 28204 | United States |
| Pinehurst Cardiology Consultants | Pinehurst | North Carolina | 28374 | United States |
| Christ Hospital - Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Regional Cardiovascular Medical Center | Steubenville | Ohio | 43952 | United States |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | United States |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74101 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Associated Cardiologists | Harrisburg | Pennsylvania | 17112 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Cardiovascular Associates of Rhode Island | Providence | Rhode Island | 02904 | United States |
| Columbia Cardiology | Columbia | South Carolina | 29204 | United States |
| PeeDee Cardiology Associates | Florence | South Carolina | 29505 | United States |
| Heart Doctors | Rapid City | South Dakota | 57701 | United States |
| Memphis Heart Clinic | Memphis | Tennessee | 37501 | United States |
| Amarillo Heart Group | Amarillo | Texas | 79106 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| Cardiology Care Consultants | El Paso | Texas | 79902 | United States |
| Hall Garcia Cardiology | Houston | Texas | 77030 | United States |
| Houston Electrophysiology Associates | Houston | Texas | 77030 | United States |
| Willowbrook Cardiovascular Associates | Houston | Texas | 77030 | United States |
| EP Heart | The Woodlands | Texas | 77384 | United States |
| Tyler Cardiovascular Consultants | Tyler | Texas | 75701 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84790 | United States |
| Virginia Heart | Falls Church | Virginia | 22042 | United States |
| Richmond Cardiology Associates | Mechanicsville | Virginia | 23116 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| St. Joseph Hospital | Bellingham | Washington | 98225 | United States |
| Swedish Medical Center | Seattle | Washington | 98133 | United States |
| Heart Clinics Northwest | Spokane | Washington | 99204 | United States |
| Wheaton Franciscan Healthcare | Wauwatosa | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline data includes data on the patients that received an implant or underwent an attempted implant. This does not include intent patients who were consented but did not participate in the trial and did not undergo anesthesia.
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| ID | Title | Description |
|---|---|---|
| BG000 | Implants | Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| QRS Duration | QRS Duration value unavailable for 49 subjects | Mean | Standard Deviation | Milliseconds |
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| PR Interval | PR Interval (ms) unavailable for 354 subjects | Mean | Standard Deviation | milliseconds |
| ||||||||||||||||
| Left Ventricular Ejection Fraction | Left Ventricular Ejection Fraction unavailable for 25 subjects | Mean | Standard Deviation | percentage |
| ||||||||||||||||
| Arrhythmia Conduction Disorder | Arrhythmia Conduction Disorder was unavailable for 23 subjects | Count of Participants | Participants |
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| 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 | Chronic Left Ventricular Lead-related Complication Free Rate | Posted | Number | 95% Confidence Interval | Percent free from event | Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). |
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Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
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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 | Implants | Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead | 269 | 1,303 | 117 | 1,303 | 131 | 1,303 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extracardiac Stimulation, Left Ventricular | Cardiac disorders | Systematic Assessment |
| ||
| Lead Dislodgment, Left Ventricular | Cardiac disorders | Systematic Assessment |
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| Threshold Related, Left Ventricular | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac Vessel Dissection | Surgical and medical procedures | Systematic Assessment |
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| Lead Revision for no heart failure improvement, Left Ventricular | Surgical and medical procedures | Systematic Assessment |
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| Accelerated Ventricular Rhythm | Cardiac disorders | Systematic Assessment |
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| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Pulse Generator Possible Malfunction | Product Issues | Systematic Assessment |
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| Pulse Generator Related | Surgical and medical procedures | Systematic Assessment | Lead to device connection re-evaluated |
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| Erosion/Migration | Surgical and medical procedures | Systematic Assessment |
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| Heart Failure Decompensation | Cardiac disorders | Systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Inability to provide therapy, pulse generator | Surgical and medical procedures | Systematic Assessment |
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| Infection, Procedure related | Surgical and medical procedures | Systematic Assessment |
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| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
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| Premature Ventricular Contractions (PVCs) | Cardiac disorders | Systematic Assessment |
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| Impedance Related, Atrial Lead | Cardiac disorders | Systematic Assessment |
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| Infection, Atrial Lead | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lead Dislodgment, Atrial Lead | Cardiac disorders | Systematic Assessment |
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| Sensing Related, Atrial Lead | Cardiac disorders | Systematic Assessment |
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| Threshold Related, Atrial Lead | Cardiac disorders | Systematic Assessment |
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| Cardiac Perforation, Right Ventricular | Surgical and medical procedures | Systematic Assessment |
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| Impedance Related, Right Ventricular | Cardiac disorders | Systematic Assessment |
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| Inappropriate Tachy Therapy, Right Ventricular | Cardiac disorders | Systematic Assessment |
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| Infection, Right Ventricular | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lead Dislodgment, Right Ventricular | Surgical and medical procedures | Systematic Assessment |
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| Pneumothorax, Right Ventricular | Injury, poisoning and procedural complications | Systematic Assessment |
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| Sensing Related, Right Ventricular | Cardiac disorders | Systematic Assessment |
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| Threshold Related, Right Ventricular | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extracardiac Stimulation, Left Ventricular | Cardiac disorders | Systematic Assessment |
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| Threshold Related, Left Ventricular | Cardiac disorders | Systematic Assessment |
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| Inappropriate Tachy Therapy, Pulse Generator | Cardiac disorders | Systematic Assessment |
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Early termination was granted based on study results. The study was one-armed observational. The expected performance / safety of left ventricular leads has been established; permitting comparison to a pre-defined performance standard.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trial Management - cRM franchise | Boston Scientific | 1-800-227-3422 | elaine.larson@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2013 | Jul 10, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Native Hawaiian or Pacific Islander |
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| Black or African American |
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| White |
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| Bosnian |
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| East Indian |
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| Filipino |
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| Middle Eastern |
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| Russian |
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| Unknown |
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| Hispanic or Latino |
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| Vietnamese |
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| Right Bundle Branch Block |
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| Nonspecific Intraventricular Delay |
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| No Arrhythmia Conduction Disorder |
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| Unknown |
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| The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here. | Kaplan-Meier Rate | 100 | 1-Sided | 95 | 100 | Other | Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound. |