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NCT00419354 Clinical Trial

The Impact of Right Ventricular Pacing on Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00419354
Other study ID # 4134
Secondary ID
Status Recruiting
Phase N/A
First received January 4, 2007
Last updated April 20, 2009
Start date March 2007
Est. completion date March 2010

Study information
Verified date July 2006
Source Rabin Medical Center
Contact Mordehay Vaturi, MD
Phone 97239376176
Email mvaturi@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Rabin Medical Center Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

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