Quadripolar CRT-D On Currently Approved Lead SystemS

Completed

Conditions: Heart Failure

Registration Number: NCT02232984

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The purpose of the study is to evaluate different ways to program around extracardiac stimulation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 749

Inclusion Criteria

Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead
Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol
Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria

Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is enrolled in any other concurrent study, without prior approval from BSC
Women of childbearing potential who are or might be pregnant at the time of study enrollment

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Vectors With Phrenic Nerve Stimulation (PNS)	Pre-discharge (up to 7 days post implant)	The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.

Secondary Outcome Measures

Name	Time	Method
Final LV Lead Impedance at Pre-discharge	Pre-discharge (up to 7 days post implant)	Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Final Pacing Treshold at Pre-discharge	Pre-discharge (up to 7 days post implant)	Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Final Sensing Amplitude at Pre-discharge	Pre-discharge (up to 7 days post implant)	Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems	At time of implantation (0 to 30 days post consent signature)	Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.

Trial Locations

Locations (60): Mercy Gilbert Medical Center
🇺🇸
Gilbert, Arizona, United States
Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona
🇺🇸
Phoenix, Arizona, United States
St. Joseph's Hospital
🇺🇸
Phoenix, Arizona, United States
Yuma Regional Medical Center
🇺🇸
Yuma, Arizona, United States
Cardiology Associates of Northeast Arkansas
🇺🇸
Jonesboro, Arkansas, United States
Central Arkansas Veterans Healthcare System
🇺🇸
Little Rock, Arkansas, United States
Comprehensive Cardiovascular Medical Group
🇺🇸
Bakersfield, California, United States
Cardiac Device Rhythm Specialists, Inc
🇺🇸
Los Angeles, California, United States
Desert Heart Rhythm
🇺🇸
Palm Springs, California, United States
Bradenton Cardiology Center
🇺🇸
Bradenton, Florida, United States
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Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States