Abbott Atrial Fibrillation Post Approval Study

Last updated: April 1, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysrhythmia

Atrial Fibrillation

Heart Defect

Treatment

electrophysiology study and ablation with an Abbott Ablation Catheter

Clinical Study ID

NCT05434650
ABT-CIP-10436
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must provide written informed consent prior to any clinicalinvestigation-related procedure.

  2. Documented symptomatic persistent AF, which is defined as continuous AF sustainedbeyond 7 days and less than 1 year that is documented by a physician's note AND oneof the following:

  3. a 24-hour Holter within 180 days prior to consent/enrollment, showingcontinuous AF OR

  4. two electrocardiograms (from any form of rhythm monitoring) showing continuousAF: i. that are taken at least 7 days apart but less than 12 months apart. ii. Ifelectrocardiograms are more than 12 months apart, there must be one or more SRrecordings in between or within 12 months prior to consent/enrollment NOTE: The mostrecent ECG must be within 180 days of consent/enrollment. Documented evidence of theAF episode must either be continuous AF on a 12-lead ECG or include at least 30seconds of AF from another ECG device.

  5. Subject must have failed, intolerance, or contraindication to a Class I-IV AADmedication.

  6. Able and willing to comply with all pre-, post-, and follow-up testing andrequirements

Exclusion

Exclusion Criteria:

  1. Previously diagnosed continuous AF >12 months (longstanding persistent AF)

  2. Previous left atrial surgical or catheter ablation for atrial fibrillation or aprevious 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 theinvestigator's opinion, could limit the subject's ability to participate in theclinical investigation or to comply with follow-up requirements, or impact thescientific soundness of the clinical investigation results

  10. Enrollment in an investigational study evaluating another device, biologic, or drugthat may interfere with this clinical investigation at the time of the initialprocedure or within 30 days prior to the initial procedure

  11. Investigator deems at the time of screening for inclusion in the study that thepatient's treatment plan does not or likely will not include use of the studycatheter

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: electrophysiology study and ablation with an Abbott Ablation Catheter
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
November 30, 2026

Study Description

This post-approval study is a prospective, non-randomized, single arm, multicenter, observational study to evaluate the continued safety and effectiveness of AF RF technologies, including the TactiCath SE. The primary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 12 months of follow-up (includes a 90-day blanking period). Secondary effectiveness endpoints will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 24 and 36 months of follow-up (includes a 90-day blanking period). The acute primary safety endpoint will be the rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure utilizing the study catheter. The secondary, long-term safety endpoint will be the rate of device and/or procedure-related SAEs from the index ablation procedure. An independent Clinical Event Committee (CEC) will review all Adverse Device Effects (ADEs) and SAEs and will adjudicate causality relative to the primary safety endpoints.

Connect with a study center

  • Heart Center Research, LLC.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Arkansas Cardiology

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Eisenhower Medical Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Sequoia Hospital

    Redwood City, California 94062
    United States

    Site Not Available

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • St. Patrick Hospital

    Missoula, Montana 59802
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Oklahoma Heart Hospital South

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Doylestown Hospital

    Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Methodist Hospital of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • St. Marks Hospital

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Chippenham Hospital

    Richmond, Virginia 23225
    United States

    Site Not Available

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