INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Bradycardia Clinical Trial

Official title:

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346537
• Other study ID #: 92424682
• Status: Completed
• Start date: August 6, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• INGEVITY+™ Pace/Sense Lead
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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