Clinical Trial: Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Left Ventricular Pacing to Prevent Iatrogenic Tricuspid Regurgitation Caused by Conventional Right Ventricular Pacing: a Pilot Study

Brief Summary:

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.


Detailed Summary:

We hypothesize that left ventricular pacing via a coronary sinus approach can reduce the incidence of significant tricuspid regurgitation after pacemaker implantation in patients with normal left ventricular function.

The aim of this study is to compare the degree of tricuspid regurgitation caused by pacemaker implantation between the conventional techniques of implanting a ventricular lead implanted in the right ventricular apex versus implanting a ventricular lead in a left ventricular epicardial vein via a coronary sinus approach.

The secondary objective of our study is to evaluate whether left ventricular pacing is also less likely to cause ventricular dyssynchrony and dysfunction than right ventricular apical pacing.

This study is a single centre randomised clinical pilot study comparing 2 different lead implantation techniques to be assessed using both imaging techniques and follow up for clinical outcomes.

(i) Proposed study interventions The procedures in both arms of the study will be identical except for where the ventricular lead is placed. All parts of these procedures, including all the implanting equipment and pacing leads are standard routine clinical practice. The left ventricular leads used in this study are routinely used for pacing the left ventricle in patients receiving biventricular pacemakers or defibrillators for heart failure.

The implant site will be the left or right prepectoral region and venous access will be via either an axillary or subclavian vein approach. These choices will be left to the implanting physician's discretion. Once venous access has been established successfully the patient will then be randomly allocated to either of the study a
Sponsor: National University Hospital, Singapore

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: National University Hospital, Singapore

Dates:
Date Received: December 8, 2014
Date Started: January 2015
Date Completion: June 2016
Last Updated: December 10, 2014
Last Verified: December 2014