Quadripolar CRT-D On Currently Approved Lead SystemS

Completed

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT02232984

Run by

Boston Scientific Corporation

People needed

749

Starts

2014-10-01

Expected to finish

2016-10-01

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• North Florida Regional Medical Center — Gainesville, Florida, United States
• North Florida VA — Gainesville, Florida, United States
• Northeast Cardiology Clinic — Jacksonville, Florida, United States
• Watson Center Clinic for Research — Lakeland, Florida, United States
• Charlotte Heart — Port Charlotte, Florida, United States
• Brevard Cardiovascular Res. Associates — Rockledge, Florida, United States
• Central Florida Regional — Sanford, Florida, United States
• Sarasota Memorial Hosptial — Sarasota, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• Tallahassee Memorial — Tallahassee, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta Heart Specialist — Atlanta, Georgia, United States
• AnMed Health — Augusta, Georgia, United States
• University Hospital — Augusta, Georgia, United States
• North Georgia Heart Foundation — Gainesville, Georgia, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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