Identification of the Pericardiophrenic Vein During Cardiac Device Implant Procedures to Prevent Extracardiac Stimulation

Completed

Conditions studied: Heart Failure

In brief

The primary goal of this study is to develop techniques to identify the course of the phrenic nerve in patients already undergoing cardiac resynchronization therapy (CRT) implantation or candidates for future CRT devices undergoing implantable cardioverter-defibrillator (ICD) or pacemaker implantation. Specifically, the study intends to identify the location and course of the left pericardiophrenic vein, and thus the left phrenic nerve, to guide the location for coronary vein lead placement and minimize the risk of phrenic nerve stimulation.

Key facts

Study ID

NCT01008670

Run by

Respicardia, Inc.

People needed

120

Starts

2007-12-01

Expected to finish

2010-10-01

Last updated by the study team

2010-11-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between the ages of 18 and 85 years old.
• Undergoing implantation of a CRT, ICD, or pacemaker device

You may not qualify if…

• Allergy to contrast dye
• Nursing mothers and women who are pregnant
• Patients for whom informed consent cannot be obtained.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Ohio Heart Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Baptist Memorial Hospital — Nashville, Tennessee, United States
• Sentara Norfolk General — Norfolk, Virginia, United States
• Ruhr University of Bochum — Bad Oeynhausen, Germany
• University of Mannheim — Mannheim, Germany
• Prince of Wales Hospital — Shatin, New Territories, Hong Kong
• Policlinico di Monza — Monza, Italy
• Jagiellonian University — Krakow, Poland
• Medical Military Institute — Warsaw, Poland
• Wroclaw Fourth Military Hospital — Wroclaw, Poland

Full record on ClinicalTrials.gov

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