BradycardiaNCT04583709

ECG Belt to Assess Electrical Synchronization

A study testing ECG Belt in people with Bradycardia and Heart Failure, run by Pugazhendhi Vijayaraman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia, Heart Failure
What is being tested?: ECG Belt
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 13 Jan 2021to 25 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients > 18 years of age
Patient has a previously implanted LBBP lead for bradycardia indication or heart failure indication with one of the following at Geisinger within the last 5 years:
LBBP
LBBP+LV lead
HBP+LV
Patient is willing to comply with all study procedures and be available for the duration of the study.

Who cannot join

Inability to provide informed consent
Pregnant
Enrolled in a concurrent study that may confound the results of this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

About this study

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

Read the detailed description

The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of LBBP and HOT-CRT and compare with preexisting data in traditional CRT and RVP.

Specific Objective:

To demonstrate and establish electrical resynchronization using ECG Belt Research System in Left Bundle Branch Pacing (LBBP) and HOT-CRT.
To assess ECG Belt derived native conduction parameters and compare them to LBBP and HOT-CRT.
To compare with historic ECG belt parameters obtained for right ventricular pacing/ Biventricular pacing in prior studies.

The ECG Belt study is a prospective, single-center, investigational, pre-market research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the ECG Belt Research System to assess the electrical characteristics of conduction system pacing in patients with preexisting LBBP or HOT-CRT.

Eligible patients would have successfully undergone LBBP using Medtronic 3830 lead. LBBP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak LV activation time and lead depth in the LV septum by contrast at implant and 2D echo post-implant.

ECG belt would be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using His-Bundle Pacing (HBP) or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on Right Ventricular RV pacing and traditional Biventricular pacing.

Conditions: Bradycardia, Heart Failure
Being tested: ECG Belt
Medical subject headings: Bradycardia, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04583709
Study group	Role	What they receive
ECG Belt	Experimental	ECG belt will be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using HBP or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on RV pacing and traditional Biventricular pacing. Receives: Device: ECG Belt

What is being measured

The primary outcome is the main question the study is designed to answer.

• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
Change in SDAT following LBBP measured in ms using ECG Belt
Measured: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline
Change in LV activation times measured in ms using ECG Belt
Measured: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
Change in QRS duration measured in ms using ECG Belt
Measured: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
LV dispersion measured using ECG Belt
Measured: Visit 1 Baseline- 50 minutes
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
RV dispersion measured using ECG Belt
Measured: Visit 1 Baseline- 50 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202125 Jun 2021

First posted12 Oct 2020
Study start13 Jan 2021
Primary completion25 Jun 2021
Study completion25 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BradycardiaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04583709
Sponsor's protocol ID: 2020-0465
Status last verified: Jul 2022
First submitted: 29 Sep 2020
Last updated: 22 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Vijayaraman P, Hughes G, Manganiello M, Johns A, Ghosh S. Non-invasive assessment of ventricular electrical heterogeneity to optimize left bundle branch area pacing. J Interv Card Electrophysiol. 2023 Aug;66(5):1103-1112. doi: 10.1007/s10840-022-01315-9. Epub 2022 Jul 30.
PubMed 35907107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ECG Belt to Assess Electrical Synchronization in Patients With Left Bundle Branch Pacing and His-Purkinje Conduction System Optimized Cardiac Resynchronization Therapy (ECG Belt)
ClinicalTrials.gov ID: NCT04583709
Acronym / sponsor ID: 2020-0465
Conditions: Bradycardia, Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Pugazhendhi VijayaramanUniversity, hospital or other
Collaborators: Medtronic
Study start: 13 Jan 2021 (actual)
Primary completion: 25 Jun 2021 (actual)
Study completion: 25 Jun 2021 (actual)
First posted: 12 Oct 2020 (actual)
Results: Posted 22 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of LBBP and HOT-CRT and compare with preexisting data in traditional CRT and RVP.

Specific Objective:

To demonstrate and establish electrical resynchronization using ECG Belt Research System in Left Bundle Branch Pacing (LBBP) and HOT-CRT.
To assess ECG Belt derived native conduction parameters and compare them to LBBP and HOT-CRT.
To compare with historic ECG belt parameters obtained for right ventricular pacing/ Biventricular pacing in prior studies.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ECG Belt	Experimental	Device: ECG BeltECG belt will be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using HBP or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on RV pacing and traditional Biventricular pacing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients > 18 years of age
Patient has a previously implanted LBBP lead for bradycardia indication or heart failure indication with one of the following at Geisinger within the last 5 years:
Patient is willing to comply with all study procedures and be available for the duration of the study.

Key exclusion criteria (3 listed)

Inability to provide informed consent
Pregnant
Enrolled in a concurrent study that may confound the results of this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ECG BeltECG 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	Device	ECG Belt

Primary outcome

• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
Time frame: Visit 1 Baseline-50 minutes
Change in SDAT following LBBP measured in ms using ECG Belt
• ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline
Time frame: Visit 1 Baseline-50 minutes
Change in LV activation times measured in ms using ECG Belt
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
Time frame: Visit 1 Baseline-50 minutes
Change in QRS duration measured in ms using ECG Belt
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
Time frame: Visit 1 Baseline- 50 minutes
LV dispersion measured using ECG Belt
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
Time frame: Visit 1 Baseline- 50 minutes
RV dispersion measured using ECG Belt

Results and safety

Results posted to the registry on 22 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ECG Belt	20	20

Primary outcome: • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction

Time frame: Visit 1 Baseline-50 minutes. Mean (Standard Deviation). Unit: ms

Measure	ECG Belt n = 20
SDAT at Baseline	38.6 (9.03)
SDAT at Optimized LBBAP	20.5 (7.54)

Primary outcome: • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline

Time frame: Visit 1 Baseline-50 minutes. Mean (Standard Deviation). Unit: ms

Measure	ECG Belt n = 20
LVAT at Baseline	61.4 (21)
LVAT at Optimized LBBAP	44.4 (4.3)

Primary outcome: • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options

Time frame: Visit 1 Baseline-50 minutes. Mean (Standard Deviation). Unit: ms

Measure	ECG Belt n = 20
QRSd at Baseline	152 (24)
QRSd at Optimized LBBAP	133 (20)

Primary outcome: • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline

Time frame: Visit 1 Baseline- 50 minutes. Mean (Standard Deviation). Unit: ms

Measure	ECG Belt n = 20
LV dispersion at Optimized LBBAP	11.6 (11.64)
LV dispersion at Baseline	29.5 (15.01)

Adverse events

Time frame: Study related adverse events were collected during the one year time span of enrollment and follow up. For each participant, adverse event data was collected during their time participating in the study (1 week).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECG Belt	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35907107Vijayaraman P, Hughes G, Manganiello M, Johns A, Ghosh S. Non-invasive assessment of ventricular electrical heterogeneity to optimize left bundle branch area pacing. J Interv Card Electrophysiol. 2023 Aug;66(5):1103-1112. doi: 10.1007/s10840-022-01315-9. Epub 2022 Jul 30.

Related trials for Bradycardia

RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia

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.

Pugazhendi Vijayaraman, MD principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ECG Belt in people with Bradycardia and Heart Failure, run by Pugazhendhi Vijayaraman 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 22 Aug 2022. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction (time frame: Visit 1 Baseline-50 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04583709, which also lists 1 linked publication.

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 22 Aug 2022.