N/A
N=20
ECG Belt to Assess Electrical Synchronization
Bradycardia · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04583709 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction — 38.6; 20.5 ms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ECG Belt (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pugazhendhi Vijayaraman
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction |
38.6; 20.5 | — |
| PRIMARY • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline |
61.4; 44.4 | — |
| PRIMARY • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options |
152; 133 | — |
| PRIMARY • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline |
11.6; 29.5 | — |
| PRIMARY • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline |
21.1; 42.5 | — |
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).
Eligibility Criteria
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:
- LBBP
- LBBP+LV lead
- HBP+LV
- Patient is willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria
- Inability to provide informed consent
- Pregnant
- Enrolled in a concurrent study that may confound the results of this study.
Data sourced from ClinicalTrials.gov (NCT04583709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.