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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04658940
Other study ID # CLP-21
Secondary ID CLP-21-EU
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2021
Est. completion date June 12, 2022

Study information

Verified date September 2023
Source Acutus Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT04657055

Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date June 12, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter. 2. At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG. 3. Age 18 years or older at time of consent. 4. 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. Exclusion Criteria: 1. 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). 2. Inability to entrain CTI dependent AFL by standard pacing at procedure. 3. Any prior right atrial cavotricuspid isthmus ablation. 4. Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment. 5. Any patient scheduled or anticipating an AF ablation within the follow-up period. 6. Use of amiodarone within 120 days prior to procedure. 7. Cardiac surgery within 60 days prior to enrollment. 8. ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment 9. Current unstable angina. 10. Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment. 11. Any history of a known hematologic disorder (bleeding/clotting). 12. Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment. 13. Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment. 14. Subjects with an ejection fraction less than 30% within 90 days of enrollment. 15. Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment. 16. Clinically significant structural heart disease (including moderate to severe tricuspid valve regurgitation, tricuspid valve stenosis, or tricuspid valve replacement; Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator. 17. Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment. 18. Body Mass Index (BMI) >42 kg/m2. 19. International Normalized Ratio (INR) > 3. 20. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days. 21. Women who are pregnant or plan to become pregnant within the course of their participation in the investigation. 22. Current enrollment in any other study protocol where testing or results from the study may interfere with the procedure or outcome measurements for this study. 23. Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus

Locations

Country Name City State
Belgium ZNA Middelheim Antwerpen
Belgium Jessa Ziekenhuis Hasselt
United Kingdom James Cook University Hospital Middlesbrough
United Kingdom Freeman Hospital Newcastle Upon Tyne
United States St Alphonsus Health System Boise Idaho
United States BayCare Heath Clearwater Florida
United States Ohio State Med Ctr Columbus Ohio
United States John Muir Health Concord California
United States Hartford Hospital Hartford Connecticut
United States Penn State Health Hershey Pennsylvania
United States MedStar Health Research Institute Hyattsville Maryland
United States Arrhythmia Research Group Jonesboro Arkansas
United States Lancaster General Hospital Lancaster Pennsylvania
United States Baptist Lexington Medical Center Lexington Kentucky
United States Weill Cornell New York New York
United States Celebration Hospital Orlando Florida
United States Kansas City Heart Rhythm Institute Overland Park Kansas
United States Presbyterian Medical Center Philadelphia Pennsylvania
United States AZ Cardiovascular Research Center Phoenix Arizona
United States Bayfront Health Saint Petersburg Florida
United States San Diego Cardiac Center Medical Group, Inc. San Diego California
United States Adventist Healthcare | White Oak Medical Center Silver Spring Maryland
United States Adventist Healthcare, Inc Silver Spring Maryland
United States ProMedica Physician Cardiology Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
Acutus Medical

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Withdrawn NCT04434599 - Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study N/A
Recruiting NCT05777850 - High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter N/A
Completed NCT01401361 - Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System Phase 3
Completed NCT00984204 - Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL) Phase 3
Withdrawn NCT01710150 - Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter N/A
Completed NCT01408485 - Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter N/A
Recruiting NCT00750711 - Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters N/A
Recruiting NCT03867266 - Typical Atrial Flutter, Ablation Index and Point by Point Ablation
Not yet recruiting NCT06157437 - An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter N/A
Recruiting NCT04657055 - AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU) N/A