Quadripolar CRT-D On Currently Approved Lead SystemS

N/ACompletedNCT02232984

Boston Scientific Corporation749 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

749

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Number of Vectors With Phrenic Nerve Stimulation (PNS)

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.

Time frame: Pre-discharge (up to 7 days post implant)

Secondary Outcomes

Final Pacing Treshold at Pre-discharge

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.

Time frame: Pre-discharge (up to 7 days post implant)

Final LV Lead Impedance at Pre-discharge

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.

Time frame: Pre-discharge (up to 7 days post implant)

Final Sensing Amplitude at Pre-discharge

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.

Time frame: Pre-discharge (up to 7 days post implant)

Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems

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.

Data from ClinicalTrials.gov

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