Overview

This trial is active, not recruiting.

Condition heart failure
Sponsor Boston Scientific Corporation
Start date October 2014
End date April 2016
Trial size 750 participants
Trial identifier NCT02232984, CROSS X4

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All study patients will be implanted with a BSC quadripolar 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.

Primary Outcomes

Measure
Primary Objective
time frame: Pre-discharge (up to 7 days post implant)

Secondary Outcomes

Measure
Secondary Objective 1
time frame: Pre-discharge (up to 7 days post implant)
Secondary Objective 2
time frame: At time of implantation (0 to 30 days post consent signature)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject is medically indicated for implantation with a 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

Additional Information

Official title Quadripolar CRT-D On Currently Approved Lead SystemS
Principal investigator Christopher R Ellis, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.