The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,244
The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies. The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead.
Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months
Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.
Time frame: Implant through 6 months
Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months
Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.
Time frame: Implant through 6 months
Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)
PCT measurements in the programmed configuration were collected at 3 months post-implant. Programmed configuration refers to the pacing configuration that was selected by the physician to provide LV pacing therapy. The percentage of measurements with PCT ≤ 2.5 V were calculated.
Time frame: Implant through 3 months
Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode
PCT measurements in the in the proximal zone (electrodes 2, 3, 4) were collected at 3 months post-implant. Physician investigators were instructed to use the best proximal electrode (E2, E3 or E4) as the cathode and the RV lead coil or pulse generator as the anode; best was defined as the electrode with the lowest PCT without phrenic nerve stimulation. The percentage of measurements with PCT ≤ 2.5 V were calculated.
Time frame: 3 months
Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.
Time frame: Implant through 3 months
Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner Baywood Heart Hospital
Mesa, Arizona, United States
Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States
Cardiology Associates of Northeast Arkansas, P.A.
Jonesboro, Arkansas, United States
Kaiser Permanente
Los Angeles, California, United States
USC Medical Center
Los Angeles, California, United States
Alta Bates Medical Center
Oakland, California, United States
Mercy General Hospital
Sacramento, California, United States
...and 86 more locations
Time frame: 3 months through 24 months
Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months
PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width.
Time frame: Implant through 3 months
Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months
Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months
Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months
Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months
Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
The mean detection time, in seconds, of induced VT/VF episodes occurring within 30 days of implant were evaluated. Subjects were required to implanted with RELIANCE 4-FRONT leads to be evaluated.
Time frame: Within 30 days of implant
Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months
Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months
Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant.
Time frame: 3 months
Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months
Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant.
Time frame: 3 months
Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant
Time frame: Within 30 days of implant