Quadripolar CRT-D On Currently Approved Lead SystemS (CROSS X4)

Boston Scientific

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02232984

CROSSX4

Details and patient eligibility

About

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

Enrollment: 749 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

749 participants in 1 patient group

All study patients

Description:

All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance.