Atrial Arrhythmia Clinical Trial
Official title:
Abbott Atrial Fibrillation Post Approval Study
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE)) for the treatment of AF.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 30, 2026 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year that is documented by a physician's note AND one of the following: 1. a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR 2. two electrocardiograms (from any form of rhythm monitoring) showing continuous AF: i. that are taken at least 7 days apart but less than 12 months apart. ii. If electrocardiograms are more than 12 months apart, there must be one or more SR recordings in between or within 12 months prior to consent/enrollment NOTE: The most recent ECG must be within 180 days of consent/enrollment. Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device. 3. Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication. 4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: 1. Previously diagnosed continuous AF >12 months (longstanding persistent AF) 2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar 3. Documented or known intracardiac thrombus on imaging 4. History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure 5. Patients with prosthetic valves 6. Diagnosed atrial myxoma 7. Acute illness or active systemic infection or sepsis 8. Patient is unlikely to survive the protocol follow up period of 36 months 9. Presence of other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 10. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure 11. Investigator deems at the time of screening for inclusion in the study that the patient's treatment plan does not or likely will not include use of the study catheter |
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital | Atlanta | Georgia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | Erlanger Medical Center | Chattanooga | Tennessee |
United States | Doylestown Hospital | Doylestown | Pennsylvania |
United States | Heart Center Research, LLC. | Huntsville | Alabama |
United States | Arkansas Cardiology | Little Rock | Arkansas |
United States | St. Patrick Hospital | Missoula | Montana |
United States | Centennial Medical Center | Nashville | Tennessee |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Oklahoma Heart Hospital South | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Eisenhower Medical Center | Rancho Mirage | California |
United States | Sequoia Hospital | Redwood City | California |
United States | Chippenham Hospital | Richmond | Virginia |
United States | St. Marks Hospital | Salt Lake City | Utah |
United States | Methodist Hospital of San Antonio | San Antonio | Texas |
United States | Providence Hospital | Southfield | Michigan |
United States | North Mississippi Medical Center | Tupelo | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months | AF recurrence is defined as:
Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period Repeat ablation for AF/AFL/AT following the blanking period Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period |
12 months | |
Primary | Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure | Device and/or index procedure-related SAEs are defined below:
Atrio-esophageal fistula Cardiac tamponade/perforation Death Heart block Myocardial infarction (MI) Pericarditis Phrenic nerve injury resulting in diaphragmatic paralysis Vagal nerve injury/gastroparesis Pulmonary edema (respiratory insufficiency) Pulmonary vein stenosis Stroke/cerebrovascular accident (CVA) Thromboembolism Transient ischemic attack Vascular access complications (including major bleeding events3) |
7 days | |
Secondary | the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months | AF recurrence is defined as:
Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period Repeat ablation for AF/AFL/AT following the blanking period Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period |
36 months | |
Secondary | the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months | Device and/or index procedure-related SAEs are defined below:
Atrioesophageal fistula Cardiac tamponade/perforation Death Heart block Myocardial infarction (MI) Pericarditis Phrenic nerve injury resulting in diaphragmatic paralysis Pneumothorax Pulmonary edema (respiratory insufficiency) Pulmonary vein stenosis Stroke/cerebrovascular accident (CVA) Thromboembolism Transient ischemic attack Vascular access complications (including major bleeding events) |
36 months |
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