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The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INGEVITY+â„¢ Pace/Sense Lead | Device | The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Lead-related Complication-Free Rate | This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %. | Lead Implant through 3-Months Post-Implant |
| Primary Efficacy: Pacing Capture Threshold Responder Rate | This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used. | At 3-Months Post-Implant |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) | This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for atrial leads was > 1.5 mV. | At 3-Months Post-Implant |
| Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from the investigator's general patient population indicated for dual-chamber pacemaker or CRT-P implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Devi Nair, MD | Arrhythmia Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Arrhythmia Research Group |
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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 |
|
Baseline characteristics are reported on enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | INGEVITY+ Study Participants | Enrolled INGEVITY+ Study Participants |
| 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 | Primary Safety: Lead-related Complication-Free Rate | This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %. | Posted | Number | 97.5% Confidence Interval | Percentage of leads | Lead Implant through 3-Months Post-Implant | Leads | Leads |
|
Implant through 3-months post-implant.
Only subjects implanted or attempted with an INGEVITY+ lead were considered at risk for an adverse event (N = 101).
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislodgment - related to right atrial lead | Product Issues | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensation of pacing with auto threshold - related to pulse generator | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gena Kantor | Boston Scientific | 1-800-227-3422 | gena.kantor@bsci.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 | May 12, 2020 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for ventricular leads was > 1.5 mV. |
| At 3-Months Post-Implant |
| Secondary Efficacy: Pacing Impedance in Ohms | This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms. | At 3-Months Post-Implant |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Torrance Memorial Medical Center | Torrance | California | 90505 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Cardiovascular Institute of Michigan | Clinton Township | Michigan | 48048 | United States |
| Cox Health | Springfield | Missouri | 65807 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Deborah Heart and Lung | Browns Mills | New Jersey | 08015 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Saint Thomas Health | Nashville | Tennessee | 37205 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| PeaceHealth Southwest Medical | Bellingham | Washington | 98664 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brady Arrhythmia History | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Leads |
|
|
| Primary | Primary Efficacy: Pacing Capture Threshold Responder Rate | This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used. | Of the 201 leads eligible for endpoint analysis, 15 did not contribute to data the analysis (1 had unsuccessful lead implant, 14 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data). | Posted | Number | 95% Confidence Interval | Percentage of leads | At 3-Months Post-Implant | Leads | Leads |
|
|
|
| Secondary | Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) | This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for atrial leads was > 1.5 mV. | Of the 101 right atrial leads eligible for endpoint analysis, 9 did not contribute to data the analysis due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data. | Posted | Median | Inter-Quartile Range | millivolts | At 3-Months Post-Implant | Right Atrial Leads | Right Atrial Leads |
|
|
|
|
| Secondary | Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) | This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for ventricular leads was > 1.5 mV. | Of the 100 right ventricular leads eligible for endpoint analysis, 12 did not contribute to data the analysis (1 had unsuccessful lead implant, 11 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data). | Posted | Median | Inter-Quartile Range | millivolts | At 3-Months Post-Implant | Right Ventricular Leads | Right Ventricular Leads |
|
|
|
|
| Secondary | Secondary Efficacy: Pacing Impedance in Ohms | This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms. | Of the 201 leads eligible for endpoint analysis, 5 did not contribute to data the analysis (1 had unsuccessful lead implant, 4 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data). | Posted | Mean | 90% Confidence Interval | ohms | At 3-Months Post-Implant | Leads | Leads |
|
|
|
|
| 1 |
| 101 |
| 8 |
| 101 |
| 10 |
| 101 |
| Myocardial perforation post-implant - related right atrial lead | Product Issues | Non-systematic Assessment |
|
| Hemothorax | Surgical and medical procedures | Non-systematic Assessment |
|
| Post-surgical infection (<=30 days post-implant) | Surgical and medical procedures | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Systemic infection | Infections and infestations | Non-systematic Assessment |
|
| Dislodgment - related to right atrial lead | Product Issues | Non-systematic Assessment |
|
| Dislodgment - related to right ventricular lead | Product Issues | Non-systematic Assessment |
|
| Adverse reaction | Surgical and medical procedures | Non-systematic Assessment |
|
| Chest pain | Surgical and medical procedures | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
|
| Atrial tachycardia/Other supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Cardiac disorders | Non-systematic Assessment |
|
Restriction on the PI that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is equal to 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor reserves the right to require deletion of any Confidential Information or other proprietary information of Sponsor.
| D013568 |
| Pathological Conditions, Signs and Symptoms |