INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: INGEVITY+™ Pace/Sense Lead

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Michigan
    • Clinton Township, Michigan, United States, 48048
      • Cardiovascular Institute of Michigan
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Cox Health
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Health
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Bellingham, Washington, United States, 98664
      • PeaceHealth Southwest Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: Lead-related Complication-Free Rate	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 %.	Lead Implant through 3-Months Post-Implant
Primary Efficacy: Pacing Capture Threshold Responder Rate	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.	At 3-Months Post-Implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)	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.	At 3-Months Post-Implant
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)	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.	At 3-Months Post-Implant
Secondary Efficacy: Pacing Impedance in Ohms	This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms.	At 3-Months Post-Implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Devi Nair, MD, Arrhythmia Research Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2020
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: 92424682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No