Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04657055
Other study ID # CLP-21-EU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2021
Est. completion date February 28, 2022

Study information

Verified date April 2021
Source Acutus Medical
Contact Jerald Cox, PA
Phone 762-529-6310
Email jerry.cox@acutus.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to confirm the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 28, 2022
Est. primary completion date February 28, 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:
The AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus

Locations

Country Name City State
Belgium ZNA Middelheim Antwerp
Belgium Jessa Ziekenhuis Hasselt
United Kingdom James Cook University Hospital Middlesbrough

Sponsors (1)

Lead Sponsor Collaborator
Acutus Medical

Countries where clinical trial is conducted

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
Completed NCT04658940 - AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce 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