Bradycardia
Conditions
Brief summary
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
Interventions
DEVICEINGEVITY+™ Pace/Sense Lead
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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is willing and capable of providing informed consent 2. Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator 3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual) 4. Willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol 5. Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
1. Known or suspected sensitivity to dexamethasone acetate (DXA) 2. Has a mechanical tricuspid heart valve 3. Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion) 4. Currently requiring hemo- or peritoneal dialysis 5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems 6. Intended to receive a single chamber device 7. Documented history of permanent or persistent AF 8. Currently on an active organ transplant list 9. Documented life expectancy of less than 12 months 10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Lead-related Complication-Free Rate | Lead Implant through 3-Months Post-Implant | 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 %. |
| Primary Efficacy: Pacing Capture Threshold Responder Rate | At 3-Months Post-Implant | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) | At 3-Months Post-Implant | 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. |
| Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) | At 3-Months Post-Implant | 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. |
| Secondary Efficacy: Pacing Impedance in Ohms | At 3-Months Post-Implant | This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were \> 300 ohms and \< 1300 ohms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INGEVITY+ Study Participants Enrolled INGEVITY+ Study Participants | 109 |
| Total | 109 |
Baseline characteristics
| Characteristic | INGEVITY+ Study Participants |
|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 11.3 |
| Brady Arrhythmia History Atrioventricular Block - 1st Degree | 4 Participants |
| Brady Arrhythmia History Atrioventricular Block - 2nd Degree (Intermittent) | 5 Participants |
| Brady Arrhythmia History Atrioventricular Block - 2nd Degree (Permanent) | 6 Participants |
| Brady Arrhythmia History Atrioventricular Block - 3rd Degree (Intermittent) | 2 Participants |
| Brady Arrhythmia History Atrioventricular Block - 3rd Degree (Permanent) | 4 Participants |
| Brady Arrhythmia History Chronotropic Incompetence | 7 Participants |
| Brady Arrhythmia History Sinus Arrest | 4 Participants |
| Brady Arrhythmia History Sinus Bradycardia | 72 Participants |
| Brady Arrhythmia History Sinus Node Dysfunction | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Region of Enrollment United States | 109 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 101 |
| other Total, other adverse events | 10 / 101 |
| serious Total, serious adverse events | 8 / 101 |
Outcome results
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.
Time frame: At 3-Months Post-Implant
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INGEVITY+ Leads | Primary Efficacy: Pacing Capture Threshold Responder Rate | 98.9 Percentage of leads |
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 %.
Time frame: Lead Implant through 3-Months Post-Implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INGEVITY+ Leads | Primary Safety: Lead-related Complication-Free Rate | 98.5 Percentage of 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.
Time frame: At 3-Months Post-Implant
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| INGEVITY+ Leads | Secondary Efficacy: Pacing Impedance in Ohms | 712 ohms |
p-value: <0.001Two one-sided t-tests
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.
Time frame: At 3-Months Post-Implant
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INGEVITY+ Leads | Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) | 4.3 millivolts |
p-value: <0.001Wilcoxon signed rank test
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.
Time frame: At 3-Months Post-Implant
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INGEVITY+ Leads | Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) | 15.9 millivolts |
p-value: <0.001Wilcoxon signed rank test