Abbott Atrial Fibrillation Post Approval Study

NCT05434650 | Active Not Recruiting FDA Device

• 1 other identifier: ABT-CIP-10436
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 20

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.

Conditions

Atrial Arrhythmia; Atrium; Fibrillation; Atrial Tachycardia

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months

  AF recurrence is defined as: 1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of \> 30 seconds duration following the blanking period 2. Repeat ablation for AF/AFL/AT following the blanking period 3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period 4. 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

• 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 Outcomes (2)

• the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months

  36 months

• the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months

  36 months

Study Arms (1)

Treatment group

Single arm group to receive ablation

Device: electrophysiology study and ablation with an Abbott Ablation Catheter

Interventions

electrophysiology study and ablation with an Abbott Ablation Catheter 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

Treatment group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll subjects of all genders who have drug refractory, symptomatic, persistent AF.

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Oklahoma Heart Hospital South

Oklahoma City, Oklahoma, 73135, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Methodist Hospital of San Antonio

San Antonio, Texas, 78229, United States

Location

St. Marks Hospital

Salt Lake City, Utah, 84124, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin Ruffner

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: October 21, 2022
• Primary Completion: October 22, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (20)