Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization

NeuroTherapia, Inc.

Status: Terminated

Conditions: Cardiomyopathies; Congestive Heart Failure

Treatments: Device: Biotronik Vision Guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT03253809

17-650

Details and patient eligibility

About

LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.

Full description

During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study.

The patient will then receive the left ventricular pacing lead in the standard manner.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Standard implantation for cardiac resynchronization ICD or PM implantation
• Cardiomyopathy with LVEF <35%
• QRS duration greater than 120 msec

Exclusion criteria

• Age less than 18 years

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Coronary Sinus Branch Pacing

Experimental group

Description:

After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle. ECG signals will be saved digitally for analysis

Treatment:

Device: Biotronik Vision Guidewire