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Procedure

LARIAT + PVI for Atrial Fibrillation (aMAZE Trial)

N/A
Waitlist Available
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following index pulmonary vein isolation
Awards & highlights

aMAZE Trial Summary

This trial is a prospective, controlled study evaluating the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

aMAZE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following index pulmonary vein isolation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following index pulmonary vein isolation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Secondary outcome measures
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
Atrial Fibrillation
Other outcome measures
LARIAT Technical Success

aMAZE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LARIAT + PVI Treatment GroupExperimental Treatment2 Interventions
Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation
Group II: PVI Catheter Ablation GroupActive Control1 Intervention
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LARIAT + PVI
2020
N/A
~90
Pulmonary Vein Isolation
2017
N/A
~360

Find a Location

Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor
41 Previous Clinical Trials
16,871 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
7,827 Patients Enrolled for Atrial Fibrillation
Dhanunjaya Lakkireddy, MDStudy ChairKansas City Cardiac Arrhythmia Research
28 Previous Clinical Trials
7,624 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
3,276 Patients Enrolled for Atrial Fibrillation
David J Wilber, MDStudy ChairLoyola University Department of Medicine
2 Previous Clinical Trials
254 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
254 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Heart JournalJournal
Percutaneous Alternative to the Maze Procedure for the Treatment of Persistent or Long-standing Persistent Atrial Fibrillation (amaze Trial): Rationale and Design
Lee, Randall J., Dhanunjaya Lakkireddy, Suneet Mittal, Christopher Ellis, Jason T. Connor, Benjamin R. Saville, and David Wilber. 2015. “Percutaneous Alternative to the Maze Procedure for the Treatment of Persistent or Long-standing Persistent Atrial Fibrillation (amaze Trial): Rationale and Design”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2015.09.019.
clinicaltrials.govStudy
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
2015. "aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02513797.
~63 spots leftby Apr 2025
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