Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2019-12-31

Brief Summary

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In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.

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Detailed Description

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In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.

The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.

Conditions

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Complete AV Block Sick Sinus Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right ventricular pacing

Group Type ACTIVE_COMPARATOR

RV pacing

Intervention Type DEVICE

The right ventricular lead are positioned at the right ventricular apex.

Left ventricular pacing

Group Type EXPERIMENTAL

LV pacing

Intervention Type DEVICE

The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.

Interventions

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LV pacing

The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.

Intervention Type DEVICE

RV pacing

The right ventricular lead are positioned at the right ventricular apex.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
* Paced QRS duration ≥185 ms

Exclusion Criteria

* Left ventricular ejection fraction \< 50 %
* Acute coronary syndrome
* If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
* if they had a life expectancy of less than 1 year
* if they had received a heart transplant

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No