Clinical trial NCT04346537: INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
Official title: INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the investigator's general patient population indicated for dual-chamber pacemaker or CRT-P implantation.

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


Eligibility criteria: Inclusion Criteria:

1. Subject is willing and capable of providing informed consent
2. 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
3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
4. 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
5. Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Known or suspected sensitivity to dexamethasone acetate (DXA)
2. Has a mechanical tricuspid heart valve
3. 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)
4. Currently requiring hemo- or peritoneal dialysis
5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
6. Intended to receive a single chamber device
7. Documented history of permanent or persistent AF
8. Currently on an active organ transplant list
9. Documented life expectancy of less than 12 months
10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor

Primary outcomes:
measure: Primary Safety: Lead-related Complication-Free Rate
timeFrame: Lead Implant through 3-Months Post-Implant
measure: Primary Efficacy: Pacing Capture Threshold Responder Rate
timeFrame: At 3-Months Post-Implant
Secondary outcomes:
measure: Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)
timeFrame: At 3-Months Post-Implant
measure: Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)
timeFrame: At 3-Months Post-Implant
measure: Secondary Efficacy: Pacing Impedance in Ohms
timeFrame: At 3-Months Post-Implant
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Clinton Township
country: United States
facility: Cardiovascular Institute of Michigan
state: Michigan
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung
state: New Jersey
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
Study officials:
affiliation: Arrhythmia Research Group
name: Devi Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: