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ECG Belt to Assess Electrical Synchronization

NCT04583709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-22

Study results available
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Summary

The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare with preexisting data in traditional Cardiac Resynchronization Therapy (CRT) and Right Ventricular Pacing (RVP).

Conditions

Interventions

DEVICE

ECG Belt

ECG Belt Research System Procedure LBBP Native conduction RV pacing if available Bipolar LBBP Unipolar LBBP - nonselective and selective (different outputs) Fusion pacing with native conduction at different Atrioventricular (AV) delays HOT-CRT Native conduction HBP / LBBP HOT-CRT AV delay optimization. Medtronic Device (pacemaker/ICD) based Holter recording during the ECG belt recording

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Pugazhendhi Vijayaraman

    lead OTHER

Principal Investigators

  • Pugazhendi Vijayaraman, MD · Geisinger Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2021-06-25
Completion
2021-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583709 on ClinicalTrials.gov