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Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study

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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
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.


Condition or disease Intervention/treatment Phase
Tricuspid Valve Insufficiency Sick Sinus Syndrome Device: LV pacing Device: RV pacing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Biventricular ventricular function and dyssynchrony [ Time Frame: 6 months ]
    Echocardiographically determined LV function, RV function, interventricular and intra ventricular dyssynchrony at 6 months.

  2. Major cardiovascular events [ Time Frame: 6 months ]
    Cardiovascular mortality, hospitalizations, heart failure, stroke, MI

  3. All cause mortality [ Time Frame: 6 months ]
    All cause mortality

  4. Biomarkers of heart failure [ Time Frame: 6 months ]
    Change in plasma concentrations over 6 months of NT-proBNP, hsTnT and GDF15

  5. Lead performance parameters [ Time Frame: 6 months ]
    Change in lead parameters over 6 months, including sensed R wave amplitude, impedance, capture threshold.

  6. Procedural complications and device related complications [ Time Frame: 6 months ]
    Procedural complications and device related complications



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Aged ≥21 years and able to give informed consent. The age limit is so that all patients are able to give informed consent personally.

Exclusion Criteria:

1. 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.

  1. Life expectancy less than 1 year due to medical co-morbidities.
  2. Previous mechanical prosthetic tricuspid valve replacement, precluding the implantation of a right ventricular apical lead.
  3. Tricuspid regurgitation that is at least moderate in severity.
  4. Complex congenital heart disease precluding the placement of either a right ventricular apical lead or left ventricular lead via the coronary sinus
  5. 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.
  6. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314897


Contacts
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Contact: Timothy Chia 65-6772 7563 medccpt@nus.edu.sg
Contact: Office of Biomedical Research 65-6516 8425 obr@nuh.com.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Toon Wei Lim, MBBS, PhD    65-67725286    toon_wei_lim@nuhs.edu.sg   
Contact: Office of Biomedical Research    65-65168425    obr@nuh.com.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Toon Wei Lim, MBBS, PhD National University Hospital, Singapore

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02314897     History of Changes
Other Study ID Numbers: 2014/00258
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: April 2017

Additional relevant MeSH terms:
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Sick Sinus Syndrome
Tricuspid Valve Insufficiency
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease
Pathologic Processes
Heart Valve Diseases