CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
ECG Beltdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04583709
NCT04583709N/ACompleted
CompareCT.gov

ECG Belt to Assess Electrical Synchronization in Patients With Left Bundle Branch Pacing and His-Purkinje Conduction System Optimized Cardiac Resynchronization Therapy (ECG Belt)

Pugazhendhi Vijayaraman·interventional·Posted Oct 12, 2020·Updated Aug 22, 2022

In Brief

A clinical study evaluating ECG Belt for Bradycardia and Heart Failure. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia, Heart Failure
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 12, 2020
Enrollment StartJan 13, 2021
Primary CompletionJun 25, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.7 years ago

Interventions

ECG Beltdevice

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