INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Completed

Brief Summary: The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
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.
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 %.

Secondary Outcome Measures

Name	Time	Method
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.

Locations (13): Cardiovascular Institute of Michigan
🇺🇸
Clinton Township, Michigan, United States
PeaceHealth Southwest Medical
🇺🇸
Bellingham, Washington, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Saint Thomas Health
🇺🇸
Nashville, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Catholic Medical Center
🇺🇸
Manchester, New Hampshire, United States
Arrhythmia Research Group
🇺🇸
Jonesboro, Arkansas, United States
Torrance Memorial Medical Center
🇺🇸
Torrance, California, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Deborah Heart and Lung
🇺🇸
Browns Mills, New Jersey, United States
Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
Cox Health
🇺🇸
Springfield, Missouri, United States
Aultman Hospital
🇺🇸
Canton, Ohio, United States