HBPNCT04930601
HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System
An observational study of HBP, run by SAMBIT MONDAL at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBP
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction.
Who may be able to join
- 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
Who cannot join
- ●Patient is ventricular pacer dependent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Orlando Cardiac & Vascular Specialists
Altamonte Springs, Florida, 32701
Sambit Mondal, MD, 407-915-5643, sambitmondal@gmail.com
About this study
Official title: HBP Synchrony Using ECG Belt
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the electrical dispersion using SDAT
Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAMBIT MONDAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SAMBIT MONDAL, Orlando Cardiac and Vascular Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930601
- Sponsor's protocol ID
- OSCMondal062021
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBP Synchrony Using ECG Belt
- ClinicalTrials.gov ID
- NCT04930601
- Acronym / sponsor ID
- OSCMondal062021
- Conditions
- HBP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SAMBIT MONDALUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- ●Patient is ventricular pacer dependent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the electrical dispersion using SDAT
Time frame: 1 year
Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for HBP
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando Cardiac & Vascular Specialists
Altamonte Springs, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBP, run by SAMBIT MONDAL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the electrical dispersion using SDAT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.