AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
NCT ID: NCT04658940
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
115 participants
INTERVENTIONAL
2021-03-25
2022-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-randomized
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus
Interventions
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AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Acutus Medical
INDUSTRY
Responsible Party
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Locations
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AZ Cardiovascular Research Center
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
John Muir Health
Concord, California, United States
San Diego Cardiac Center Medical Group, Inc.
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
BayCare Heath
Clearwater, Florida, United States
Celebration Hospital
Orlando, Florida, United States
Bayfront Health
St. Petersburg, Florida, United States
St Alphonsus Health System
Boise, Idaho, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Baptist Lexington Medical Center
Lexington, Kentucky, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Adventist Healthcare | White Oak Medical Center
Silver Spring, Maryland, United States
Adventist Healthcare, Inc
Silver Spring, Maryland, United States
Weill Cornell
New York, New York, United States
Ohio State Med Ctr
Columbus, Ohio, United States
ProMedica Physician Cardiology
Toledo, Ohio, United States
Penn State Health
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
ZNA Middelheim
Antwerp, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP-21-EU
Identifier Type: OTHER
Identifier Source: secondary_id
CLP-21
Identifier Type: -
Identifier Source: org_study_id
NCT04657055
Identifier Type: -
Identifier Source: nct_alias
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