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Identification of the Pericardiophrenic Vein During Cardiac Device Implant Procedures to Prevent Extracardiac Stimulation (IDPV-003)

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ClinicalTrials.gov Identifier: NCT01008670
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 24, 2010
Sponsor:
Information provided by:
Respicardia, Inc.

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.

Condition or disease
Heart Failure

Detailed Description:

Phrenic nerve stimulation from cardiac resynchronization therapy (CRT) is a common adverse event occurring in 1.5-3% of patients and sometimes as high as 10%. Phrenic nerve stimulation is frequently observed during the implantation procedure but often appears shortly after implantation as well. Clinically, dyspnea, cough, and hiccups can occur, some of which are uncomfortable and not tolerated by the patient for very long periods of time. Resolution of these clinical outcomes requires repositioning the left coronary vein lead in a second procedure with its attendant serious clinical sequelae. As CRT leads become smaller the incidence of phrenic nerve stimulation is likely to increase.

The risk of phrenic nerve stimulation (PNS) exists during CRT implantation and is only minimally dependent of the type of coronary lead and highly dependent upon location of the left coronary vein lead in relationship to the left phrenic nerve and stimulation strength. Tedrow et al. demonstrated in a cohort of 71 patients PNS can reach 16% if stimulation strength is increased to maximize mechanical benefit of CRT. No current methods have been able to predict PNS, the one likely method of preventing PNS is to identify the location of the phrenic nerve in the specific patient, as confirmed by visualization and ability to stimulate the phrenic nerve and by maximizing the distance between the coronary vein lead position and nerve.

In order to reduce the incidence of phrenic nerve stimulation, Vaseghi performed non-selective injections of contrast media and was able to identify the left pericardiophrenic vein in only about 12% of patients undergoing biventricular pacemaker placement. However, in these patients, identification of the left pericardiophrenic vein provides a landmark for positioning of the left ventricular (LV) lead that totally eliminated the incidence of phrenic nerve pacing.

The relationship of cardiac structures to the right and left phrenic nerves is generally known but is significantly variable between patients. There is no imaging or other clinically available modality that allows the physician to identify the location of the left phrenic nerve and attempt to avoid it during the left coronary vein lead implant procedure.

The pericardiophrenic veins are a deep collateral venous drainage of the pericardium, pleura and diaphragm and lie adjacent the phrenic nerves on both the right and left sides between the parietal pericardium and adjacent pleura. The ostium of the left pericardiophrenic vein is usually in the left brachiocephalic vein opposite the entrance of the left jugular vein. The left phrenic vein is located in the general vicinity of the thymic veins which often have multiple ostia in close proximity. There are several case reports in the literature of inadvertent cannulation of the pericardiophrenic veins with Swan-Ganz catheters, central venous catheters and one report of cannulation with a pacing lead leading to inadvertent phrenic nerve pacing.

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of the Pericardiophrenic Vein During Cardiac Device Implant Procedures to Prevent Extracardiac Stimulation
Study Start Date : December 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Group/Cohort
Device Implant Recipients
Patients undergoing CRT implantation, or candidates for future CRT devices currently undergoing ICD or pacemaker implantation.



Primary Outcome Measures :
  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. [ Time Frame: Methods are assessed acutely (during the lead implant procedure) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008670


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Ohio
Ohio Heart Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
United States, Tennessee
Baptist Memorial Hospital
Nashville, Tennessee, United States
United States, Virginia
Sentara Norfolk General
Norfolk, Virginia, United States
Germany
Ruhr University of Bochum
Bad Oeynhausen, Germany
University of Mannheim
Mannheim, Germany
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Italy
Policlinico di Monza
Monza, Italy
Poland
Jagiellonian University
Krakow, Poland
Medical Military Institute
Warsaw, Poland
Wroclaw Fourth Military Hospital
Wroclaw, Poland
Sponsors and Collaborators
Respicardia, Inc.
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Responsible Party: Lori Austin, Cardiac Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01008670    
Other Study ID Numbers: CCI-Venography
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 24, 2010
Last Verified: November 2010
Keywords provided by Respicardia, Inc.:
Cardiac resynchronization therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases