Quadripolar CRT-D On Currently Approved… | Clinical Trial

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Gilbert Medical Center, Gilbert, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Vectors With Phrenic Nerve Stimulation (PNS)

Time frame: 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 outcomes

Final Pacing Treshold at Pre-discharge

Time frame: 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 LV Lead Impedance at Pre-discharge

Time frame: 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 Sensing Amplitude at Pre-discharge

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: CROSS X4

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 8, 2014
Registry last updated: Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed