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

NCT03253809 | Terminated Results FDA Device

• 1 other identifier: 17-650
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiomyopathies; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• QRS Frequency at Each Paced Location

  Time frequency analysis performed at each location

  Baseline

Study Arms (1)

Coronary Sinus Branch Pacing

EXPERIMENTAL

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

Interventions

Biotronik Vision Guidewire DEVICE

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

Coronary Sinus Branch Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Age less than 18 years

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Mark Neibauer
• Organization: Cleveland Clinic

niebaum@ccf.org

216-444-3160

Study Officials

• Mark J Niebauer, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nonrandomized survey of different pacing sites in the coronary veins.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: July 12, 2017
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)