Completed
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
What is being tested
INGEVITY lead
Device
Who is being recruted
Cardiac Conduction System Disease+7
+ Arrhythmias, Cardiac
+ Arrhythmia, Sinus
Over 18 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: October 2012
Summary
Principal SponsorBoston Scientific Corporation
Last updated: March 10, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads
Principal SponsorBoston Scientific Corporation
Last updated: March 10, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1060 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiac Conduction System DiseaseArrhythmias, CardiacArrhythmia, SinusCardiovascular DiseasesHeart BlockHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBradycardiaSick Sinus Syndrome
Criteria
4 inclusion criteria required to participate
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 age 18 or above, or of legal age to give informed consent specific to state and national law
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 willing and capable of providing informed consent
9 exclusion criteria prevent from participating
Subject has a mechanical tricuspid heart valve
Subject has a sensitivity to dexamethasone acetate (DXA)
Subject has documented life expectancy of less than 12 months
Subject has or has had any pacing or ICD system implants
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalINGEVITY lead implant
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 78 locations
Cardiovascular Consultants, LTD
Glendale, United StatesPima Heart Physicians, PC
Tucson, United StatesSharp Grossmont Hospital
La Mesa, United StatesCompleted78 Study Centers