Clinical Research & Results

Published Studies
Ongoing Clinical Trials

Published Studies

Extensive clinical evidence supports the wearable cardioverter defibrillator (WCD) as a therapy for protection from sudden cardiac death (SCD). The following research demonstrates the safe and effective use of the LifeVest® WCD for a wide range of patient conditions or situations.

VEST
Randomized controlled trial of over 2,000 patients to study the use of the WCD and its effect on sudden death and total mortality in early post-MI, low-EF (EF ≤ 35%) patients at 90 days, including an initial intent-to-treat analysis and subsequent per-protocol analysis. Read more

WCD Meta-Analysis
Analysis of 11 studies, with almost 20,000 non-overlapping patients prescribed the WCD, which assessed the occurrence of sustained VT events and evaluated the use and effectiveness of WCDs among at-risk cardiac patients. Read more

AArD Algorithm Performance Evaluation
Retrospective analysis of 96,000 commercial LifeVest WCD patients to study the impact of the Advanced Arrhythmia Discrimination Algorithm (AArD), a noise processing algorithm, on the arrhythmia alarm rate. Read more

WEARIT-II Registry
Prospective registry of 2,000 US patients assessed the safety and efficacy of the WCD in real world setting. Read more

WEARIT France
Multi-centered, observational study of more than 1,000 French patients evaluated WCD efficacy and patient experience in real world setting. Read more

U.S. National WCD Experience
Retrospective study compared the long-term survival of more than 3,500 patients who wore the WCD to the patients who underwent first ICD implantation. Read more

German WCD Study
Retrospective study of more than 6,000 German patients evaluated safety and efficacy of the WCD in the German healthcare system. Read more

Post-MI WCD Study
Retrospective study examined the utility of providing the WCD to more than 8,400 patients determined to be at high risk of SCD during the post-MI waiting period. Read more

Post-Revascularization Study
Retrospective observational parallel cohort study compared mortality outcomes of nearly 5,000 post-revascularization high-risk SCD patients. Read more

WEARIT/BIROAD
Multi-center clinical trial which led to FDA approval of the LifeVest WCD. Read more
 

Ongoing Clinical Trials

ZOLL is committed to research that advances the medical community’s understanding and management of cardiac patients. For more information or to get involved, email [email protected].

Benefit of µCor™ in Ambulatory Decompensated Heart Failure (BMAD HF)
A prospective, observational clinical trial that documents thoracic fluid index, ECG, body position, and activity measurements taken by a wearable sensor worn by heart failure patients. Read more at clinicaltrials.gov.

Heart Failure Optimization (HF Opt)
International trial to document the improvement in ejection fraction (EF) during six months of optimizing medical therapy after a first hospitalization for a new heart failure diagnosis with EF less than 35%. Read more at clinicaltrials.gov.

HEARIT Registry
A prospective registry to evaluate cardiac acoustic biomarkers in heart failure patients collected by a patient’s WCD. Read more at clinicaltrials.gov.