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Heart FailureIDPV-003NCT01008670

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

An observational study of Heart Failure, run by Respicardia, Inc. at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure
How many people
120 participants
Where
13 sitesin 5 countries
Study dates
Dec 2007to Oct 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

United States6 sites
  • Johns Hopkins University

    Baltimore, Maryland

  • University of Alabama

    Birmingham, Alabama

  • Ohio Heart Hospital

    Cincinnati, Ohio

  • The Ohio State University

    Columbus, Ohio

  • Baptist Memorial Hospital

    Nashville, Tennessee

  • Sentara Norfolk General

    Norfolk, Virginia

Other trials in United States

Poland3 sites
  • Jagiellonian University

    Krakow

  • Medical Military Institute

    Warsaw

  • Wroclaw Fourth Military Hospital

    Wroclaw

Other trials in Poland

Germany2 sites
  • Ruhr University of Bochum

    Bad Oeynhausen

  • University of Mannheim

    Mannheim

Other trials in Germany

Hong Kong1 site
  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

Italy1 site
  • Policlinico di Monza

    Monza

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Heart Failure
Keywords
Cardiac resynchronization therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01008670
Study groupRoleWhat they receive
Device Implant RecipientsPatients undergoing CRT implantation, or candidates for future CRT devices currently undergoing ICD or pacemaker implantation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Methods are assessed acutely (during the lead implant procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008670
Sponsor's protocol ID
CCI-Venography
Acronym
IDPV-003
Status last verified
Nov 2010
First submitted
4 Nov 2009
Last updated
24 Nov 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Respicardia, Inc. at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Poland, Germany, Hong Kong, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.

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