Bradycardia, Heart Failure
Conditions
Brief 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 Ventricular Pacing (RVP).
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.
Interventions
DEVICEECG 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
Sponsors
Medtronic
Pugazhendhi Vijayaraman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients \> 18 years of age 2. 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 3. Patient is willing to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
1. Inability to provide informed consent 2. Pregnant 3. Enrolled in a concurrent study that may confound the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction | 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 | 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 | 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 | Visit 1 Baseline- 50 minutes | LV dispersion measured using ECG Belt |
| • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline | Visit 1 Baseline- 50 minutes | RV dispersion measured using ECG Belt |
Countries
United States
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | ECG Belt |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Time frame: Visit 1 Baseline-50 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECG Belt | • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline | LVAT at Baseline | 61.4 ms | Standard Deviation 21 |
| ECG Belt | • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline | LVAT at Optimized LBBAP | 44.4 ms | Standard Deviation 4.3 |
Primary
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
LV dispersion measured using ECG Belt
Time frame: Visit 1 Baseline- 50 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECG Belt | • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline | LV dispersion at Optimized LBBAP | 11.6 ms | Standard Deviation 11.64 |
| ECG Belt | • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline | LV dispersion at Baseline | 29.5 ms | Standard Deviation 15.01 |
Primary
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
Change in QRS duration measured in ms using ECG Belt
Time frame: Visit 1 Baseline-50 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECG Belt | • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options | QRSd at Baseline | 152 ms | Standard Deviation 24 |
| ECG Belt | • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options | QRSd at Optimized LBBAP | 133 ms | Standard Deviation 20 |
Primary
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
RV dispersion measured using ECG Belt
Time frame: Visit 1 Baseline- 50 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECG Belt | • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline | RV dispersion at Optimized LBBAP | 21.1 ms | Standard Deviation 7.84 |
| ECG Belt | • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline | RV dispersion at Baseline | 42.5 ms | Standard Deviation 9.31 |
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
Time frame: Visit 1 Baseline-50 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECG Belt | • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction | SDAT at Baseline | 38.6 ms | Standard Deviation 9.03 |
| ECG Belt | • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction | SDAT at Optimized LBBAP | 20.5 ms | Standard Deviation 7.54 |