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AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

NCT04658940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-09-28

Study results available
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Summary

The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.

Conditions

  • Typical Atrial Flutter

Interventions

DEVICE

AcQBlate® Force Sensing Ablation System

Percutaneous catheter ablation of the cavotricuspid isthmus

Sponsors & Collaborators

  • Acutus Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2022-05-12
Completion
2022-06-12
FDA Device
Yes

Countries

  • United States
  • Belgium
  • United Kingdom

Study Locations

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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 NCT04658940 on ClinicalTrials.gov