NCT04658940

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
3 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

December 2, 2020

Results QC Date

August 10, 2023

Last Update Submit

September 7, 2023

Conditions

Typical Atrial Flutter

Outcome Measures

Primary Outcomes (2)

  • Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)

    Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)

    7 days

  • Subjects Achieving Acute Procedural Success

    Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.

    20 minutes post ablation

Study Arms (1)

Non-randomized

EXPERIMENTAL

All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.

Device: AcQBlate® Force Sensing Ablation System

Interventions

AcQBlate® Force Sensing Ablation SystemDEVICE

Percutaneous catheter ablation of the cavotricuspid isthmus

Also known as: AcQBlate Force Sensing System, AcQBlate Force
Non-randomized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
  • At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
  • Age 18 years or older at time of consent.
  • Subjects are willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations.

You may not qualify if:

  • In the opinion of the Investigator, any contraindication to the planned atrial ablation, including contraindications to anticoagulation therapy and any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, chronic kidney disease).
  • Inability to entrain CTI dependent AFL by standard pacing at procedure.
  • Any prior right atrial cavotricuspid isthmus ablation.
  • Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
  • Any patient scheduled or anticipating an AF ablation within the follow-up period.
  • Use of amiodarone within 120 days prior to procedure.
  • Cardiac surgery within 60 days prior to enrollment.
  • ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
  • Current unstable angina.
  • Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
  • Any history of a known hematologic disorder (bleeding/clotting).
  • Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
  • Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
  • Subjects with an ejection fraction less than 30% within 90 days of enrollment.
  • Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

AZ Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

John Muir Health

Concord, California, 94520, United States

Location

San Diego Cardiac Center Medical Group, Inc.

San Diego, California, 92123, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

BayCare Heath

Clearwater, Florida, 33756, United States

Location

Celebration Hospital

Orlando, Florida, 32803, United States

Location

Bayfront Health

St. Petersburg, Florida, 33701, United States

Location

St Alphonsus Health System

Boise, Idaho, 83704, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Baptist Lexington Medical Center

Lexington, Kentucky, 40503, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 80784, United States

Location

Adventist Healthcare | White Oak Medical Center

Silver Spring, Maryland, 20904, United States

Location

Adventist Healthcare, Inc

Silver Spring, Maryland, 20904, United States

Location

Weill Cornell

New York, New York, 10021, United States

Location

Ohio State Med Ctr

Columbus, Ohio, 43201, United States

Location

ProMedica Physician Cardiology

Toledo, Ohio, 43615, United States

Location

Penn State Health

Hershey, Pennsylvania, 17033-0850, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Results Point of Contact

Title
Karen Stephens, Director Clinical Affairs
Organization
Acutus Medical
karen.stephens@acutus.com
442-232-6080

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

March 25, 2021

Primary Completion

May 12, 2022

Study Completion

June 12, 2022

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(20)GB(2)BE(2)