N/A
Completed N=109
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
Bradycardia
Source: ClinicalTrials.gov NCT04346537 ↗
Enrolled (actual)
109
Serious AEs
7.9%
Results posted
May 2022
Primary outcomePrimary: Primary Safety: Lead-related Complication-Free Rate — 98.5 Percentage of leads
Summary
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety: Lead-related Complication-Free Rate |
98.5 | — |
| PRIMARY Primary Efficacy: Pacing Capture Threshold Responder Rate |
98.9 | — |
| SECONDARY Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) |
4.3 | < 0.001 sig |
| SECONDARY Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) |
15.9 | < 0.001 sig |
| SECONDARY Secondary Efficacy: Pacing Impedance in Ohms |
712 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is willing and capable of providing informed consent
- 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
- Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
- 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
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
- Known or suspected sensitivity to dexamethasone acetate (DXA)
- Has a mechanical tricuspid heart valve
- 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)
- Currently requiring hemo- or peritoneal dialysis
- Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
- Intended to receive a single chamber device
- Documented history of permanent or persistent AF
- Currently on an active organ transplant list
- Documented life expectancy of less than 12 months
- Enrolled in any other concurrent study unless prior approval is received from the Sponsor
Data sourced from ClinicalTrials.gov (NCT04346537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.