This trial is active, not recruiting.

Conditions bradycardia, sinus node dysfunction
Treatment ingevity lead
Sponsor Boston Scientific Corporation
Start date October 2012
End date January 2015
Trial size 1060 participants
Trial identifier NCT01688843, BSC-CDM00048360


The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
INGEVITY lead implant
ingevity lead

Primary Outcomes

Safety 1
time frame: Lead implant through 3 month follow up
Safety 2
time frame: 3 months through 12 months post implant
Effectiveness 1
time frame: Lead implant through 3 month follow up
Effectiveness 2
time frame: Lead implant through 3 month follow up
Effectiveness 3
time frame: Lead implant through 3 month follow up

Secondary Outcomes

Safety 3
time frame: Implant through 12 months (including available data beyond 12 months)

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
Principal investigator Charles Love, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.