N/A
N=76
Metabolic Mapping and Cardiac Resynchronization
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03420833 ↗Enrolled (actual)
76
Serious AEs
9.2%
Results posted
Jan 2025
Primary outcome: Primary: Change in Left Ventricle End-Systolic Volume Index (LVESVI) — -11.6; -4.1 mL/m^2 — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiac resynchronization therapy pacemaker (CRT-P) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yong-Mei Cha
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricle End-Systolic Volume Index (LVESVI) |
-11.6; -4.1 | 0.0001 sig |
| PRIMARY Number of Subjects Experiencing Any System-Related Complications |
2; 2 | — |
| SECONDARY Number of Subjects Admitted to the Hospital for Heart Failure |
0; 0 | — |
| SECONDARY Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months |
0.1; -0.3 | 0.024 sig |
| SECONDARY Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds |
1; 0 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) |
5.3; 2.2 | 0.0001 sig |
| SECONDARY Number of Subjects Who Die in One Year |
0; 3 | — |
Summary
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).
Eligibility Criteria
Inclusion Criteria
- Left Ventricular Ejection Fraction (LVEF) 35%-50%
- New York Heart Association (NYHA) class I-II
- QRS duration of ≥120ms
- Left bundle branch block (LBBB)
- Patient is able to receive a transvenous pectoral CRT implant
- Patient is able to sign informed consent
- Two echocardiograms are required to confirm a stable reduced LVEF
- Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)
Exclusion Criteria
- Advanced comorbid conditions with life expectancy <1 year
- Patient is <18 of years of age
- Patient has a CRT device
- Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
- Unwilling or unable to return for required follow-up visits
- Patient decides study participation is cost-prohibited
Data sourced from ClinicalTrials.gov (NCT03420833). 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.