N/A
N=242
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
Non-left Bundle Branch Block · Ischemic or Non-ischemic Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT01983293 ↗Enrolled (actual)
242
Serious AEs
6.3%
Results posted
Jan 2019
Primary outcome: Primary: Number of Patients With Improved Clinical Composite Score — 86; 45 Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- QLV based implant strategy (Device); Standard of care implant strategy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Improved Clinical Composite Score |
86; 45 | 0.001 sig |
Summary
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
Eligibility Criteria
Inclusion Criteria
- Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
- Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
- Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy
- Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
- Are 18 years or older, or of legal age to give informed consent specific to state and local law
- Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
- Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system
- Undergoing left ventricular lead placement via a surgical or epicardial approach
- Cardiomyopathy due solely to valvular disease that is not repaired/replaced
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study
- LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
- Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms
- Persistent or permanent atrial fibrillation
- Pacemaker dependent
- Patients who are being upgraded primarily due to right ventricular pacing
- Women who are pregnant or who plan to become pregnant during the clinical trial
- Life expectancy < 1 year
Data sourced from ClinicalTrials.gov (NCT01983293). 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.