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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG Belt | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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 | 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 | 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 | Visit 1 Baseline-50 minutes |
| • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline | LV dispersion measured using ECG Belt | Visit 1 Baseline- 50 minutes |
| • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline | RV dispersion measured using ECG Belt | Visit 1 Baseline- 50 minutes |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pugazhendi Vijayaraman, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35907107 | Derived | 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. |
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Patients will be identified by clinician referrals, or by review of the electronic health record (EHR) of patients. Research staff will contact potential subjects and invite them to participate, either in clinic or by phone.
First subject enrolled: 13 Jan 2021 Last subject enrolled: 18 Jun 2021 (follow up completed 25 Jun 2021)
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| ID | Title | Description |
|---|---|---|
| FG000 | ECG Belt | The ECG Belt Research System will be used to evaluate and assess the electrical characteristics of conduction system pacing in patients with preexisting LBBAP or HOT-CRT. 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. ECG Belt: ECG Belt Research System Procedure All patients will share the same recruitment process, inclusion and exclusion criteria and same procedures. Patients are allocated to ECG Belt group and data will be collected according to their preexisting therapy. Data includes: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ECG Belt | 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. ECG Belt: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | • 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 | Posted | Mean | Standard Deviation | ms | Visit 1 Baseline-50 minutes |
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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).
Patients will be asked about adverse events related to the use of the ECG Belt. These data will not be monitored in real time and patients will be educated on the need to contact their physician directly should they have any medical concern.
Only ECG Belt related SAE/AE's will be collected and reported and then assessed if it is device related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECG Belt | The ECG Belt Research System will be used to evaluate and assess the electrical characteristics of conduction system pacing in patients with preexisting LBBAP or HOT-CRT. 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. ECG Belt: ECG Belt Research System Procedure All patients will share the same recruitment process, inclusion and exclusion criteria and same procedures. Patients are allocated to ECG Belt group and data will be collected according to their preexisting therapy. Data includes: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Product related adverse event | Product Issues | Non-systematic Assessment | Redness on skin under electrodes of ECG Belt system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pugazhendhi Vijayaraman | Geisinger Heart Institute | 5708085444 | pvijayaraman1@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2020 | Jun 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2021 | Jun 20, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | • 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 | Posted | Mean | Standard Deviation | ms | Visit 1 Baseline-50 minutes |
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| Primary | • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options | Change in QRS duration measured in ms using ECG Belt | Posted | Mean | Standard Deviation | ms | Visit 1 Baseline-50 minutes |
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| Primary | • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline | LV dispersion measured using ECG Belt | Posted | Mean | Standard Deviation | ms | Visit 1 Baseline- 50 minutes |
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| Primary | • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline | RV dispersion measured using ECG Belt | Posted | Mean | Standard Deviation | ms | Visit 1 Baseline- 50 minutes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |