HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System

NCT ID: NCT04930601

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-05-01

Brief Summary

The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.

Conditions

HBP

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead
• Patient has intrinsic AV conduction
• Normal EF, defined as EF >50%, as shown on recent echo within last 12 months
• Patient is willing and able to comply with the protocol
• Patient is 18 years of age or older

Exclusion Criteria

●Patient is ventricular pacer dependent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SAMBIT MONDAL

OTHER

Sponsor Role: lead

Responsible Party

SAMBIT MONDAL

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Orlando Cardiac & Vascular Specialists

Altamonte Springs, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Sambit Mondal, MD

Role: primary

sambitmondal@gmail.com

407-915-5643

Other Identifiers

OSCMondal062021

Identifier Type: -

Identifier Source: org_study_id