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Left Bundle Area Versus Selective His Bundle Pacing

2019-09-23 04:51:40 | BioPortfolio

Summary

This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients are responsible for following up with their doctor every 3 months, for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.

Description

This is a single center, open label, prospective randomized pilot study to evaluate the capture threshold of His Bundle versus left bundle area pacing. Secondary analysis will focus on inter-patient electrocardiographic and echocardiographic hemodynamic parameters of intrinsic conduction, versus pacing at three different pacing sites. Symptomatic bradyarrhythmias are effectively treated with cardiac pacemakers.The amount of pacing by the lead positioned in the bottom chamber of the heart at traditional sites such as the right ventricular apex have been associated with increased rates of atrial fibrillation, heart failure, and mortality. Traditional pacing sites result in cardiac electromechanical dyssynchrony, for which alternate pacing sites to minimize these untoward effects have been sought. HIS bundle pacing, which utilizes a patient's native conduction, has demonstrated improved electrical synchrony and left ventricular function when compared to traditional pacing at the tip of the bottom chamber. Barriers to wide spread application to this technique include the His bundle anatomic location and its attendant difficulties associated with implant, as well as higher capture thresholds leading to decreased battery duration of the pacemaker. An alternative to HIS bundle pacing is placing the lead just past the HIS bundle area, which is further in the heart, and to actively fixate the lead into the interventricular septum. This is referred to as Left Bundle Pacing, as it may electrically capture the left bundle, which would simulate a patient's native conduction. The researchers will evaluate the two different pacing sites (HIS bundle and Left Bundle area sites) to determine how effectively the heart pumps with each pacing site. The researchers will compare these to traditional pacing sites (apex) and to non paced parameters.

Patients requiring pacemaker implant will be screened for study eligibility and approached for informed consent. Baseline assessments including echocardiogram and ECG will be obtained. Once enrolled, the researchers will randomize patients to one of two arms. One arm will fixate the ventricular pacemaker lead to the HIS bundle area while the other arm will have the leads fixed into the left bundle area. Baseline assessments including echocardiogram and ECG. Before the pacing wires are inserted, pacing at three positions (traditional, HIS bundle and left bundle area) will be evaluated and echocardiographic images obtained. The pacemaker wires will be connected in accordance with randomization group. The day after the procedure, a chest x-ray, EKG and pacemaker evaluation will be performed. After leaving hospital, the patient will be assessed at 3 months, 6 months and 12 months. An echocardiogram will be obtained at 3 months post procedure. At 6 and 12 months post procedure, an EKG and pacemaker evaluation will be performed.

Study Design

Conditions

Bradycardia

Intervention

Select Secure pacing lead

Location

Beaumont Health System
Royal Oak
Michigan
United States
48073

Status

Not yet recruiting

Source

William Beaumont Hospitals

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:40-0400

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