Clinical trial NCT04658940: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Official title: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Typical Atrial Flutter
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
timeFrame: 7 days
measure: Subjects Achieving Acute Procedural Success
timeFrame: 20 minutes post ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AZ Cardiovascular Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Concord
country: United States
facility: John Muir Health
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center Medical Group, Inc.
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: BayCare Heath
state: Florida
city: Orlando
country: United States
facility: Celebration Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Health
state: Florida
city: Boise
country: United States
facility: St Alphonsus Health System
state: Idaho
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Lexington
country: United States
facility: Baptist Lexington Medical Center
state: Kentucky
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Silver Spring
country: United States
facility: Adventist Healthcare | White Oak Medical Center
state: Maryland
city: Silver Spring
country: United States
facility: Adventist Healthcare, Inc
state: Maryland
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Columbus
country: United States
facility: Ohio State Med Ctr
state: Ohio
city: Toledo
country: United States
facility: ProMedica Physician Cardiology
state: Ohio
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Center
state: Pennsylvania
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References: