Trial Outcomes & Findings for ECG Belt to Assess Electrical Synchronization (NCT NCT04583709)

NCT ID: NCT04583709

Last Updated: 2022-08-22

Results Overview

Change in SDAT following LBBP measured in ms using ECG Belt

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Visit 1 Baseline-50 minutes
• Results posted on: 2022-08-22

Participant Flow

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)

Participant milestones

Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ECG Belt to Assess Electrical Synchronization

Baseline characteristics by cohort

Measure	ECG Belt n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 Baseline-50 minutes

Change in SDAT following LBBP measured in ms using ECG Belt

Outcome measures

Measure	ECG Belt n=20 Participants 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
• 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 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

PRIMARY outcome

Timeframe: Visit 1 Baseline-50 minutes

Change in LV activation times measured in ms using ECG Belt

Outcome measures

Measure	ECG Belt n=20 Participants 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
• 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 Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline LVAT at Optimized LBBAP	44.4 ms Standard Deviation 4.3

PRIMARY outcome

Timeframe: Visit 1 Baseline-50 minutes

Change in QRS duration measured in ms using ECG Belt

Outcome measures

Measure	ECG Belt n=20 Participants 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
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options QRSd at Baseline	152 ms Standard Deviation 24
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options QRSd at Optimized LBBAP	133 ms Standard Deviation 20

PRIMARY outcome

Timeframe: Visit 1 Baseline- 50 minutes

LV dispersion measured using ECG Belt

Outcome measures

Measure	ECG Belt n=20 Participants 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
• 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 Analysis of LV Dispersion of HOT-CRT Compared to Baseline LV dispersion at Baseline	29.5 ms Standard Deviation 15.01

PRIMARY outcome

Timeframe: Visit 1 Baseline- 50 minutes

RV dispersion measured using ECG Belt

Outcome measures

Measure	ECG Belt n=20 Participants 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
• 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 Analysis of RV Dispersion of HOT-CRT Compared to Baseline RV dispersion at Baseline	42.5 ms Standard Deviation 9.31

Adverse Events

ECG Belt

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

ECG Belt n=20 participants at risk 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

Product Issues Product related adverse event

5.0% 1/20 • Number of events 1 • 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.

Additional Information

Pugazhendhi Vijayaraman

Geisinger Heart Institute

Phone: 5708085444

Email: pvijayaraman1@geisinger.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place