Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study
|ClinicalTrials.gov Identifier: NCT02314897|
Recruitment Status : Unknown
Verified April 2017 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : December 11, 2014
Last Update Posted : February 26, 2018
Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex. It is now known that tricuspid regurgitation (TR) frequently results from this and may lead to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an epicardial vein via the coronary sinus has been widely practiced due to the advent of biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients undergoing pacemaker implantation.
Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection fraction <40% will be randomly allocated to receive either conventional RV pacing or LV pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least moderate TR. Other endpoints include biventricular function, ventricular dyssynchrony, complications of device implantation, mortality and major cardiovascular events.
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Valve Insufficiency Sick Sinus Syndrome||Device: LV pacing Device: RV pacing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Left Ventricular Pacing to Prevent Iatrogenic Tricuspid Regurgitation Caused by Conventional Right Ventricular Pacing: a Pilot Study|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: LV pacing
Left ventricular pacing lead implanted via coronary sinus
Device: LV pacing
Left ventricular pacing lead implanted via the coronary sinus.
Active Comparator: RV pacing
Conventional right ventricular pacing lead.
Device: RV pacing
Conventional right ventricular pacing.
- Development of moderate or worse TR post implantation [ Time Frame: 6 months ]At least moderate of worsening of tricuspid regurgitation at 6 months post implantation on echocardiography
- Biventricular ventricular function and dyssynchrony [ Time Frame: 6 months ]Echocardiographically determined LV function, RV function, interventricular and intra ventricular dyssynchrony at 6 months.
- Major cardiovascular events [ Time Frame: 6 months ]Cardiovascular mortality, hospitalizations, heart failure, stroke, MI
- All cause mortality [ Time Frame: 6 months ]All cause mortality
- Biomarkers of heart failure [ Time Frame: 6 months ]Change in plasma concentrations over 6 months of NT-proBNP, hsTnT and GDF15
- Lead performance parameters [ Time Frame: 6 months ]Change in lead parameters over 6 months, including sensed R wave amplitude, impedance, capture threshold.
- Procedural complications and device related complications [ Time Frame: 6 months ]Procedural complications and device related complications
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314897
|Contact: Timothy Chia||65-6772 firstname.lastname@example.org|
|Contact: Office of Biomedical Research||65-6516 email@example.com|
|Principal Investigator:||Toon Wei Lim, MBBS, PhD||National University Hospital, Singapore|