ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Right Ventricular Pacing on Tricuspid Regurgitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00419354
Recruitment Status : Unknown
Verified July 2006 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : January 8, 2007
Last Update Posted : April 21, 2009
Sponsor:
Information provided by:
Rabin Medical Center

Brief Summary:
"1" To examine whether right ventricular pacing has an impact on tricuspid regurgitation grade that is related to pacing rather than to valve closure interference by the electrode.

Condition or disease
Tricuspid Regurgitation

Detailed Description:

"1" Traditionally, tricuspid regurgitation in the presence of pacemaker is attributed to the physical interference of the valve closure by the electrode.

"2" Right ventricular pacing may be associated with dyssynchrony in contraction of the right ventricular wall (i.e. septum and free wall.

"3" The tricuspid sub-valvar apparatus is anchored to the septum and free wall, thus may be sensitive to dyssynchrony in those wals contraction.

"4" The study hypothesis is that the dyssynchrony in right ventricular contraction, induced by pacing, may increase tricuspid regurgitation grade and that this is a mechanism is independent of the mechanical effect of the electrode on the valve closure.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2007
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients, clinically stable, with a permanent pacemaker and who are not pacemaker dependent.
Criteria

Inclusion Criteria:

  • Age >18 years
  • Permanent pacemaker

Exclusion Criteria:

  • Epicardial pacing
  • Left ventricular dysfunction
  • Organic tricuspid regurgitation
  • Bi-ventricular pacemaker
  • Atrial fibrillation
  • Complete pacemaker dependence

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): NCT00419354


Contacts
Contact: Mordehay Vaturi, MD 97239376176 mvaturi@clalit.org.il

Locations
Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordehay Vaturi, MD    97239376176    mvaturi@clalit.org.il   
Principal Investigator: Mordehay Vaturi, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordehay Vaturi, MD Department of Cardiology, Rabin Medical Center

Responsible Party: Mordehay Vaturi/MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00419354     History of Changes
Other Study ID Numbers: 4134
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: April 21, 2009
Last Verified: July 2006

Keywords provided by Rabin Medical Center:
Pacemaker
Tricuspid regurgitation

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases