Tricuspid RegurgitationNCT00419354
The Impact of Right Ventricular Pacing on Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients, clinically stable, with a permanent pacemaker and who are not pacemaker dependent.
Who may be able to join
- Age >18 years
- Permanent pacemaker
Who cannot join
- Epicardial pacing
- Left ventricular dysfunction
- Organic tricuspid regurgitation
- Bi-ventricular pacemaker
- Atrial fibrillation
- Complete pacemaker dependence
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Mordehay Vaturi, MD, 97239376176, mvaturi@clalit.org.il
Mordehay Vaturi, MD
About this study
"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.
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Keywords
- Pacemaker, Tricuspid regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mordehay Vaturi, MD, Principal investigator, Department of Cardiology, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419354
- Sponsor's protocol ID
- 4134
- Status last verified
- Jul 2006
- First submitted
- 4 Jan 2007
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Right Ventricular Pacing on Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT00419354
- Acronym / sponsor ID
- 4134
- Conditions
- Tricuspid Regurgitation
- Keywords
- Pacemaker, Tricuspid regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients, clinically stable, with a permanent pacemaker and who are not pacemaker dependent.
Key inclusion criteria (2 listed)
- Age >18 years
- Permanent pacemaker
Key exclusion criteria (6 listed)
- Epicardial pacing
- Left ventricular dysfunction
- Organic tricuspid regurgitation
- Bi-ventricular pacemaker
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordehay Vaturi, MD principal investigator
Department of Cardiology, Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Rabin Medical Center at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mordehay Vaturi, MD (97239376176, mvaturi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Apr 2009.