The Impact of Right Ventricular Pacing on Tricuspid Regurgitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00419354
First received: January 4, 2007
Last updated: April 20, 2009
Last verified: July 2006
  Purpose

"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
Tricuspid Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Rabin Medical Center:

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mordehay Vaturi/MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00419354     History of Changes
Other Study ID Numbers: 4134
Study First Received: January 4, 2007
Last Updated: April 20, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Pacemaker
Tricuspid regurgitation

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

ClinicalTrials.gov processed this record on October 19, 2014