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The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INGEVITY lead | Experimental | INGEVITY lead implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INGEVITY lead | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) | Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4% | Lead implant through 3 month follow up |
| Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months) | Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%. | 3 months through 12 months post implant |
| Safety 3 - Hazard Rate of Lead-Related Complications | Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1. | Implant through 12 months (including available data beyond 12 months) |
| Effectiveness 1 | The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V | Lead implant through 3 month follow up |
| Effectiveness 2(Right Atrium) | P-wave sensed amplitude at three months post-implant > 1.5 mV | Lead implant through 3 month follow up |
| Effectiveness 2(Right Ventricle) |
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| Measure | Description | Time Frame |
|---|---|---|
| Ancillary Safety | Lead-related complication-free rate | From 3 to 60 months post-implant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Love, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | United States | ||
| Cardiovascular Consultants, LTD |
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| ID | Title | Description |
|---|---|---|
| FG000 | INGEVITY Study Participants | Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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R-wave sensed amplitude at three months post-implant > 5 mV |
| Lead implant through 3 month follow up |
| Effectiveness 3 | Clinically acceptable pacing impedance between 300 Ω and 1300 Ω | Lead implant through 3 month follow up |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Pima Heart Physicians, PC | Tucson | Arizona | 85712 | United States |
| Sharp Grossmont Hospital | La Mesa | California | 91942 | United States |
| Orange County Heart Institute | Orange | California | 92868 | United States |
| Eisenhower Medical Center | Rancho Mirage | California | 92270-3221 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Cardiology Associates of Fairfield County | Trumbull | Connecticut | 06611 | United States |
| West Florida Cardiology Network, LLC | Largo | Florida | 33770 | United States |
| University Community Hospital | Tampa | Florida | 33613 | United States |
| Wellstar Research Institute | Marietta | Georgia | 30060 | United States |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | United States |
| Indiana University Health La Porte Hospital | La Porte | Indiana | 46350 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Southern Kentucky Heart Institute | Bowling Green | Kentucky | 42101 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Michigan CardioVascular Institute | Saginaw | Michigan | 48601 | United States |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | 08080 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| Staten Island University Hospital | Staten Island | New York | 10309 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Lindner Center for Research and Education at Christ Hosp | Cincinnati | Ohio | 45219 | United States |
| University Hospital, Inc. | Cincinnati | Ohio | 45219 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Northwest Ohio Cardiology Consultants | Toledo | Ohio | 43615 | United States |
| Coastal Cardiology | Charleston | South Carolina | 29407 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| South Austin Hospital | Austin | Texas | 78745 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| North Texas Heart Center | Dallas | Texas | 75231 | United States |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | 76104 | United States |
| Trinity Mother Frances Health System | Tyler | Texas | 75701 | United States |
| University of Utah Hospital and Clinics | Salt Lake City | Utah | 84132 | United States |
| Bon Secours Heart & Vascular Institute | Richmond | Virginia | 23230 | United States |
| PeaceHealth St. Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | United States |
| Wheeling Hospital Inc. | Wheeling | West Virginia | 26003 | United States |
| Wheaton Franciscan Healthcare | Glendale | Wisconsin | 53212 | United States |
| St. Mary's Madison | Madison | Wisconsin | 53715 | United States |
| St. Andrew's War Memorial Hospital | Brisbane | Queensland | 4001 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Medizinische Univ.-Kliniken Graz | Graz | 8036 | Austria |
| AKH Linz | Linz | 4021 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | 4600 | Austria |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| AZ Groeninge Campus | Kortrijk | 8500 | Belgium |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2W IT7 | Canada |
| Skejby Sygehus | Aarhus | 8200 | Denmark |
| Roskilde University Hospital | Roskilde | 4000 | Denmark |
| CHU La Timone Hospital | Marseille | 13005 | France |
| NCN Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner | Chemnitz | 09116 | Germany |
| Uniklinik Köln | Cologne | 50931 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Otto-von-Guericke-Universitaet Magdeburg | Magdeburg | 39120 | Germany |
| Prince of Wales Hospital | Shatin | 999077 | Hong Kong |
| Azienda Ospedaliera Universitaria Integrata di Verona | Verona | 37126 | Italy |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| University of Malaya Medical Centre | Kuala Lumpur | 50603 | Malaysia |
| Centro Hospitalar do Porto - Hospital de Santo Antonio | Porto | 4099 - 001 | Portugal |
| Hospital de Santarem | Santarém | 2005-177 | Portugal |
| Hospital Clinico Y Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario Nuestra Senora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Doctor Peset | Valencia | 46017 | Spain |
| Clinico de Valladolid | Valladolid | 47012 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| Chiang Mai Heart Center Medical School Hospital | Chiang Mai | 50200 | Thailand |
| Basildon and Thurrock University Hospitals NHS | Basildon | Essex | SS16 5NL | United Kingdom |
| Belfast City Hospital | Belfast | BT9 7 | United Kingdom |
| Wrexham Maelor Hospital | Wrexham | LL13 7TD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INGEVITY Lead | INGEVITY lead implant |
| 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 |
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| Region of Enrollment | Number | 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 | Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) | Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4% | Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of leads complication-free | Lead implant through 3 month follow up | Implant/Attempted Leads | Implant/Attempted Leads |
|
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| |||||||||||||||||||||||||
| Primary | Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months) | Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%. | Leads still in service and implanted in actively followed participants at 92 days were included in analysis. | Posted | Number | 95% Confidence Interval | percentage of leads complication-free | 3 months through 12 months post implant | Implant/Attempted Leads | Implant/Attempted Leads |
|
| ||||||||||||||||||||||||||
| Primary | Safety 3 - Hazard Rate of Lead-Related Complications | Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1. | Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis. | Posted | Number | 95% Confidence Interval | hazard rate of lead-related complication | Implant through 12 months (including available data beyond 12 months) | Leads Implanted/Attempted | Leads Implanted/Attempted |
|
| ||||||||||||||||||||||||||
| Primary | Effectiveness 1 | The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V | Posted | Mean | 95% Confidence Interval | volts | Lead implant through 3 month follow up | Implant/Attempted Leads | Implant/Attempted Leads |
|
| |||||||||||||||||||||||||||
| Primary | Effectiveness 2(Right Atrium) | P-wave sensed amplitude at three months post-implant > 1.5 mV | Posted | Mean | 95% Confidence Interval | mV | Lead implant through 3 month follow up | Implant/Attempted Leads | Implant/Attempted Leads |
|
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| Primary | Effectiveness 2(Right Ventricle) | R-wave sensed amplitude at three months post-implant > 5 mV | Posted | Mean | 95% Confidence Interval | mV | Lead implant through 3 month follow up | Implant/Attempted Leads | Implant/Attempted Leads |
|
| |||||||||||||||||||||||||||
| Primary | Effectiveness 3 | Clinically acceptable pacing impedance between 300 Ω and 1300 Ω | Posted | Mean | 95% Confidence Interval | Ω | Lead implant through 3 month follow up | Implant/Attempted Leads | Implant/Attempted Leads |
|
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| Other Pre-specified | Ancillary Safety | Lead-related complication-free rate | Leads eligible for endpoint analyses | Posted | Number | 95% Confidence Interval | percentage of leads complication-free | From 3 to 60 months post-implant | Leads | Leads |
|
|
Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
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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 | INGEVITY Study Participants | 93 | 1,060 | 532 | 1,041 | 621 | 1,041 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulse Generator | Product Issues | Non-systematic Assessment | Includes: Oversensing - Defibrillation Rate response inappropriate Inappropriate AV delay Pacemaker-mediated tachycardia (PMT) Erosion Infection (> 30 days post-implant) Migration |
| |
| Right Atrial (RA) Lead - INGEVITY Related | Product Issues | Non-systematic Assessment | 564 patients were attempted/implanted with a INGEVITY RA lead, therefore that is the number at risk for an adverse event |
| |
| RA Lead - Other (Non-INGEVITY Lead) | Product Issues | Non-systematic Assessment | 858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event |
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| Right Ventricular (RV) Lead - INGEVITY-related | Product Issues | Non-systematic Assessment | Includes: Unable to capture - RV - INGEVITY-related Elevated threshold - RV - INGEVITY-related Extracardiac stimulation - RV - INGEVITY-related Conductor coil fracture - RV - INGEVITY-related Dislodgment - RV - INGEVITY-related |
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| RV Lead - Other (Non-INGEVITY Lead) | Product Issues | Non-systematic Assessment | Includes: Other - RV Lead - Other |
| |
| Left-Ventricular (LV) Lead | Product Issues | Non-systematic Assessment | Includes: Elevated threshold - LV Extracardiac stimulation - LV Dislodgment - LV |
| |
| Procedure | Surgical and medical procedures | Non-systematic Assessment |
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| Cardiovascular - Heart Failure | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular - Non-Heart Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Other | General disorders | Non-systematic Assessment |
| ||
| Unclassified | Investigations | Non-systematic Assessment |
| ||
| Non-cardiovascular | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulse Generator | Product Issues | Non-systematic Assessment |
| ||
| RA Lead - INGEVITY-related | Product Issues | Non-systematic Assessment | 564 patients were attempted/implanted with an INGEVITY RA lead, therefore that is the number at risk for an adverse event |
| |
| RA Lead - Other | Product Issues | Non-systematic Assessment | 858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event |
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| RV Lead - INGEVITY-related | Product Issues | Non-systematic Assessment |
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| LV Lead | Product Issues | Non-systematic Assessment | 47 patients were attempted/implanted with any LV lead, therefore that is the number at risk for an adverse event |
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| Procedure | Surgical and medical procedures | Non-systematic Assessment |
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| Cardiovascular - HF | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular - Non-HF | Cardiac disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Unclassified | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gena Kantor, MPH | Boston Scientific | 1-800-227-3422 | gena.kantor@bsci.com |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
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| United Kingdom |
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| Malaysia |
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| Thailand |
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| Portugal |
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| Spain |
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| Canada |
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| Austria |
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| Sweden |
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| Belgium |
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| Denmark |
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| Italy |
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| Australia |
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| France |
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| Germany |
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| Implant/Attempted Leads |
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| Leads Implanted/Attempted |
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