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

NCT01008670 | Completed

• 1 other identifier: CCI-Venography
• Study Type: observational
• Target: 120
• Locations: 5 countries
• Sites: 13

Brief Summary

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.

Conditions

Heart Failure

Keywords

Cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is to determine if methods can be developed for identifying the course of the left vein, thus the location of the phrenic nerve, during a device implant procedure.

  Methods are assessed acutely (during the lead implant procedure)

Study Arms (1)

Device Implant Recipients

Patients undergoing CRT implantation, or candidates for future CRT devices currently undergoing ICD or pacemaker implantation.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients currently under the care of an electrophysiologist or cardiac device implanter who are scheduled to receive a CRT device, or those patients receiving an ICD or pacemaker device who are future candidates for CRT device implantation.

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.

Sponsors & Collaborators

• Respicardia, Inc.: lead

Study Sites (13)

University of Alabama

Birmingham, Alabama, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Ohio Heart Hospital

Cincinnati, Ohio, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

Baptist Memorial Hospital

Nashville, Tennessee, United States

Location

Sentara Norfolk General

Norfolk, Virginia, United States

Location

Ruhr University of Bochum

Bad Oeynhausen, Germany

Location

University of Mannheim

Mannheim, Germany

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Policlinico di Monza

Monza, Italy

Location

Jagiellonian University

Krakow, Poland

Location

Medical Military Institute

Warsaw, Poland

Location

Wroclaw Fourth Military Hospital

Wroclaw, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 6, 2009
• Study Start: December 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 24, 2010

Record last verified: 2010-11

Locations

IT (1); HK (1); US (6); DE (2); PL (3)