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

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

Study Overview

• Status: Terminated
• Conditions: Cardiomyopathies; Congestive Heart Failure
• Intervention / Treatment: Device: Biotronik Vision Guidewire

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronary Sinus Branch Pacing; 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	Device: Biotronik Vision Guidewire; The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QRS Frequency at Each Paced Location	Time frequency analysis performed at each location	Baseline

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Mark J Niebauer, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies
• Other Study ID Numbers: 17-650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No