Abbott Atrial Fibrillation Post Approval Study

NCT ID: NCT05434650

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-21
• Study Completion Date: 2026-11-30

Brief 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.

Detailed 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.

Conditions

Atrial Arrhythmia; Atrium; Fibrillation; Atrial Tachycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment group

Single arm group to receive ablation

electrophysiology study and ablation with an Abbott Ablation Catheter

Intervention Type: DEVICE

During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat

Interventions

electrophysiology study and ablation with an Abbott Ablation Catheter

During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Ruffner

Role: STUDY_DIRECTOR

Abbott

Locations

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

Countries

United States

Other Identifiers

ABT-CIP-10436

Identifier Type: -

Identifier Source: org_study_id