INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

NCT04346537 | Completed Results FDA Device

• 1 other identifier: 92424682
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)

  At 3-Months Post-Implant

• Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)

  At 3-Months Post-Implant

• Secondary Efficacy: Pacing Impedance in Ohms

  At 3-Months Post-Implant

Interventions

INGEVITY+™ Pace/Sense Lead DEVICE

The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (13)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cardiovascular Institute of Michigan

Clinton Township, Michigan, 48048, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart and Lung

Browns Mills, New Jersey, 08015, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

PeaceHealth Southwest Medical

Bellingham, Washington, 98664, United States

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gena Kantor
• Organization: Boston Scientific

gena.kantor@bsci.com

1-800-227-3422

Study Officials

• Devi Nair, MD

  Arrhythmia Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: August 6, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 14, 2022
• Results First Posted: May 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)