N/A
Completed N=1,060
Safety and Performance Study of the INGEVITY Lead
Bradycardia · Sinus Node Dysfunction
Source: ClinicalTrials.gov NCT01688843 ↗
Enrolled (actual)
1,060
Serious AEs
51.1%
Results posted
Nov 2017
Primary outcomePrimary: Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) — 98.4 percentage of leads complication-free
Summary
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) |
98.4 | — |
| PRIMARY Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months) |
99.7 | — |
| PRIMARY Safety 3 - Hazard Rate of Lead-Related Complications |
0.23 | — |
| PRIMARY Effectiveness 1 |
0.67 | — |
| PRIMARY Effectiveness 2(Right Atrium) |
4.8 | — |
| PRIMARY Effectiveness 2(Right Ventricle) |
16.5 | — |
| PRIMARY Effectiveness 3 |
773 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is willing and capable of providing informed consent
- Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines
- Subject is 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
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
- Subject has or has had any pacing or ICD system implants
- Subject has a sensitivity to dexamethasone acetate (DXA)
- Subject has a mechanical tricuspid heart valve
- Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries
- Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable)
- Subject is currently on the active heart transplant list
- Subject has documented life expectancy of less than 12 months
- Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant
- Subjects currently requiring dialysis
Data sourced from ClinicalTrials.gov (NCT01688843). 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.