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

NCT ID: NCT03253809

Last Updated: 2022-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2021-11-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiomyopathies Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Nonrandomized survey of different pacing sites in the coronary veins.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Biotronik Vision Guidewire

Intervention Type DEVICE

The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.

Interventions

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Biotronik Vision Guidewire

The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Niebauer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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17-650

Identifier Type: -

Identifier Source: org_study_id

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