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The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study patients | All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Vectors With Phrenic Nerve Stimulation (PNS) | The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems. | Pre-discharge (up to 7 days post implant) |
| Measure | Description | Time Frame |
|---|---|---|
| Final Pacing Treshold at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Pre-discharge (up to 7 days post implant) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from the center's general population who are indicated for a CRT-D. All study subjects will be implanted with the BSC DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D). Subjects may have a previously implanted/will be receiving an approved quadripolar left ventricular lead.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R Ellis, MD | Vanderbilt University Medical Center, Nashville, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | United States | ||
| Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona |
A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Patients | All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Final LV Lead Impedance at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Pre-discharge (up to 7 days post implant) |
| Final Sensing Amplitude at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Pre-discharge (up to 7 days post implant) |
| Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate. | At time of implantation (0 to 30 days post consent signature) |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| St. Joseph's Hospital | Phoenix | Arizona | 85013 | United States |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | United States |
| Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | 72401 | United States |
| Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | 72114 | United States |
| Comprehensive Cardiovascular Medical Group | Bakersfield | California | 93309 | United States |
| Cardiac Device Rhythm Specialists, Inc | Los Angeles | California | 90033 | United States |
| Desert Heart Rhythm | Palm Springs | California | 92262 | United States |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | United States |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States |
| North Florida VA | Gainesville | Florida | 32610 | United States |
| Northeast Cardiology Clinic | Jacksonville | Florida | 32216 | United States |
| Watson Center Clinic for Research | Lakeland | Florida | 33805 | United States |
| Charlotte Heart | Port Charlotte | Florida | 33952 | United States |
| Brevard Cardiovascular Res. Associates | Rockledge | Florida | 32955 | United States |
| Central Florida Regional | Sanford | Florida | 32771 | United States |
| Sarasota Memorial Hosptial | Sarasota | Florida | 34239 | United States |
| Northside Hospital | St. Petersburg | Florida | 33709 | United States |
| Tallahassee Memorial | Tallahassee | Florida | 32308 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Atlanta Heart Specialist | Atlanta | Georgia | 30342 | United States |
| AnMed Health | Augusta | Georgia | 29621 | United States |
| University Hospital | Augusta | Georgia | 30901 | United States |
| North Georgia Heart Foundation | Gainesville | Georgia | 30501 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| West Suburban Hospital | Oak Park | Illinois | 60302 | United States |
| Central DuPage Medical Center | Winfield | Illinois | 60190 | United States |
| Lutheran Hospital | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital | Fort Wayne | Indiana | 46843 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Ark-La-Tex Cardiology, APMC | Shreveport | Louisiana | 71103 | United States |
| Willis Knighton | Shreveport | Louisiana | 71105 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Hurley Hospital | Flint | Michigan | 48532 | United States |
| Genesys Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| Lakeland Medical Center | Saint Joseph | Michigan | 49085 | United States |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| Desert Springs | Las Vegas | Nevada | 89169 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Atlanticare Regional Medical Center | Atlantic City | New Jersey | 08401 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mercy Hospital/ Buffalo Heart Group | Buffalo | New York | 14215 | United States |
| Genesis Health System | Zanesville | Ohio | 43701 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Mercer Bucks Cardiology | Newtown | Pennsylvania | 18940 | United States |
| Regional Hospital of Scranton | Scranton | Pennsylvania | 18510 | United States |
| Core CV Research | Jackson | Tennessee | 38305 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Houston Arrhythmia Associates | Houston | Texas | 77024 | United States |
| Houston Cardiovascular Associates | Houston | Texas | 77030 | United States |
| Heart Institute of East Texas | Lufkin | Texas | 75904 | United States |
| Woodlands North Houston Heart Ctr | The Woodlands | Texas | 17350 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Hunter Holmes VA Medical Center | Richmond | Virginia | 23249 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Belin Healthcare | Green Bay | Wisconsin | 54301 | United States |
| Successfully Implanted |
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| COMPLETED |
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| NOT COMPLETED |
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Of the 749 enrolled subjects, 742 subjects provided baseline demographics information. Six were early withdrawals and one additional was not implanted with LV lead.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Patients | All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance. |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Left Ventricular Ejection Fraction (LVEF) % | Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients. | Mean | Standard Deviation | % |
| ||||||||||||||||
| QRS width | Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients. | Mean | Standard Deviation | ms |
|
| 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 | Number of Vectors With Phrenic Nerve Stimulation (PNS) | The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems. | Posted | Number | Number of Pacing vectors with PNS | Pre-discharge (up to 7 days post implant) |
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| Secondary | Final Pacing Treshold at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Posted | Mean | Standard Deviation | Volts | Pre-discharge (up to 7 days post implant) |
|
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| Secondary | Final LV Lead Impedance at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Posted | Mean | Standard Deviation | Ohms | Pre-discharge (up to 7 days post implant) |
|
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| Secondary | Final Sensing Amplitude at Pre-discharge | Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. | Posted | Mean | Standard Deviation | Milivolts | Pre-discharge (up to 7 days post implant) |
|
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| Secondary | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate. | Posted | Mean | Standard Deviation | Minutes | At time of implantation (0 to 30 days post consent signature) |
|
From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
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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 | All Study Patients | All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. | 1 | 749 | 16 | 749 | 11 | 749 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse reaction - general | Injury, poisoning and procedural complications | Systematic Assessment |
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| Adverse drug reaction - respiratory | Injury, poisoning and procedural complications | Systematic Assessment |
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| Inadvertent VT/VF | Cardiac disorders | Systematic Assessment |
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| Hematoma pocket <= 30 days | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dislodgement - undersensing RV | Cardiac disorders | Systematic Assessment |
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| Dislodgement - no reported signs - RA | Cardiac disorders | Systematic Assessment |
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| Elevated threshold - RV | Cardiac disorders | Systematic Assessment |
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| Dislodgment - no reported signs - LV | Cardiac disorders | Systematic Assessment |
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| Coronary venous dissection | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dislodgment - no reported signs - RV | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislodgement - no reported signs - RA | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Venous dissection | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eszter Pais | Boston Scientific | 6515825307 | eszter.pais@bsci.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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