Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study

NCT02314897 | Unknown DMC

• 1 other identifier: 2014/00258
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Valve Insufficiency; Sick Sinus Syndrome

Outcome Measures

Primary Outcomes (1)

• Development of moderate or worse TR post implantation

  At least moderate of worsening of tricuspid regurgitation at 6 months post implantation on echocardiography

  6 months

Secondary Outcomes (6)

• Biventricular ventricular function and dyssynchrony

  6 months

• Major cardiovascular events

  6 months

• All cause mortality

  6 months

• Biomarkers of heart failure

  6 months

• Lead performance parameters

  6 months

Study Arms (2)

LV pacing

EXPERIMENTAL

Left ventricular pacing lead implanted via coronary sinus

Device: LV pacing

RV pacing

ACTIVE COMPARATOR

Conventional right ventricular pacing lead.

Device: RV pacing

Interventions

LV pacing DEVICE

Left ventricular pacing lead implanted via the coronary sinus.

LV pacing

RV pacing DEVICE

Conventional right ventricular pacing.

RV pacing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing dual chamber permanent pacemaker implantation for sick sinus syndrome. This is defined as symptomatic sinus node dysfunction manifest as sinus pauses or excessive sinus bradycardia and is diagnosed on continuous ECG monitoring or ambulatory ECG recording (Holter study).
• Aged ≥21 years and able to give informed consent. The age limit is so that all patients are able to give informed consent personally.

You may not qualify if:

• \. Left ventricular ejection fraction \<40%. 2. Mobitz Type 2 second degree atrioventricular block, 2:1 atrioventricular block, high degree atrioventricular block or complete heart block.
• Life expectancy less than 1 year due to medical co-morbidities.
• Previous mechanical prosthetic tricuspid valve replacement, precluding the implantation of a right ventricular apical lead.
• Tricuspid regurgitation that is at least moderate in severity.
• Complex congenital heart disease precluding the placement of either a right ventricular apical lead or left ventricular lead via the coronary sinus
• Vascular or coronary sinus anatomy unfavourable to either conventional RV lead or left ventricular lead implantation as confirmed on a coronary sinus venography at the time of implantation.
• Pregnancy.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Toon Wei Lim, MBBS, PhD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Chia

CONTACT

65-6772 7563; medccpt@nus.edu.sg

Office of Biomedical Research

CONTACT

65-6516 8425; obr@nuh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 26, 2018

Record last verified: 2017-04

Locations

SG (1)