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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03253809
• Other study ID #: 17-650
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: November 2, 2021

Study information

• Verified date: February 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Biotronik Vision Guidewire
The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QRS Frequency at Each Paced Location	Time frequency analysis performed at each location	Baseline