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

Primary Purpose

Cardiomyopathies, Congestive Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biotronik Vision Guidewire
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiomyopathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary Sinus Branch Pacing

Arm 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

Outcomes

Primary Outcome Measures

QRS Frequency at Each Paced Location
Time frequency analysis performed at each location

Secondary Outcome Measures

Full Information

First Posted
August 16, 2017
Last Updated
February 11, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03253809
Brief Title
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
Official Title
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Issue with trial administration/conduct
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies, Congestive Heart Failure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Nonrandomized survey of different pacing sites in the coronary veins.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coronary Sinus Branch Pacing
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Biotronik Vision Guidewire
Intervention Description
The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
Primary Outcome Measure Information:
Title
QRS Frequency at Each Paced Location
Description
Time frequency analysis performed at each location
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Niebauer, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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