Abbott Atrial Fibrillation Post Approval Study

Running, not enrolling

Conditions studied: Atrial Arrhythmia, Atrium; Fibrillation, Atrial Tachycardia

In brief

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. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.

Key facts

Study ID

NCT05434650

Run by

Abbott Medical Devices

People needed

200

Starts

2022-10-21

Expected to finish

2026-11-30

Last updated by the study team

2025-11-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• 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:
• a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR
• 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.
• Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if…

• Previously diagnosed continuous AF >12 months (longstanding persistent AF)
• 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
• Documented or known intracardiac thrombus on imaging
• History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure
• Patients with prosthetic valves
• Diagnosed atrial myxoma
• Acute illness or active systemic infection or sepsis
• Patient is unlikely to survive the protocol follow up period of 36 months
• 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
• 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
• 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

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• Sequoia Hospital — Redwood City, California, United States
• Northside Hospital — Atlanta, Georgia, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Providence Hospital — Southfield, Michigan, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• St. Patrick Hospital — Missoula, Montana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Oklahoma Heart Hospital South — Oklahoma City, Oklahoma, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• Centennial Medical Center — Nashville, Tennessee, United States
• Methodist Hospital of San Antonio — San Antonio, Texas, United States
• St. Marks Hospital — Salt Lake City, Utah, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Chippenham Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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