Recruiting

HIS Pacing & Intrinsic Conduction

Sponsor:

SAMBIT MONDAL

Code:

NCT04930601

Conditions

HBP

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT04930601

Start date

Jun 1, 2021

Status verified date

Jun, 2021

Completion date

May 1, 2022

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Characterize the electrical dispersion using SDAT [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Orlando Cardiac & Vascular Specialists

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Sambit Mondal, MD

407-915-5643sambitmondal@gmail.com

More Information

Sponsor

SAMBIT MONDAL

Last update posted

Jun 18, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SAMBIT MONDAL on 2021-06-18.