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aMAZE Trial Continued Access Protocol

NCT04468334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-03-12

No results posted yet for this study

Summary

aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites.

Conditions

Interventions

DEVICE

LARIAT + PVI

LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • David J Wilber, MD · Loyola University Department of Medicine

  • Dhanunjaya Lakkireddy, MD · Kansas City Cardiac Arrhythmia Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-09
Primary Completion
2023-04-24
Completion
2023-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468334 on ClinicalTrials.gov