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

Study Overview

• Status: Recruiting
• Conditions: Atrial Tachycardia; Atrial Arrhythmia; Atrium; Fibrillation
• Intervention / Treatment: Device: electrophysiology study and ablation with an Abbott Ablation Catheter

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Emily Jesser, PhD; Phone Number: +1 651 756 3454; Email: emily.jesser@abbott.com
• Study Contact Backup: Name: Sharanjeet Dhanjal; Phone Number: 714-926-8292; Email: sharanjeet.dhanjal@abbott.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Heart Center Research, LLC.
      • Contact: John Jennings, MD
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Arkansas Cardiology
      • Contact: Blake Norris, MD
  • California
    • Rancho Mirage, California, United States, 92270
      • Recruiting
      • Eisenhower Medical Center
      • Contact: Leon Feldman, MD
    • Redwood City, California, United States, 94062
      • Active, not recruiting
      • Sequoia Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital
      • Contact: Alok Gambhir, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Medical Center
      • Contact: Michael Bernard, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Patricia Tung, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Sunil Kapur, MD
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Recruiting
      • Providence Hospital
      • Contact: Shah Dipak, MD
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • North Mississippi Medical Center
      • Contact: Karthik Prasad, MD
  • Montana
    • Missoula, Montana, United States, 59802
      • Recruiting
      • St. Patrick Hospital
      • Contact: Nicholas Mantini, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Not yet recruiting
      • University of Nebraska Medical Center
      • Contact: Jason Payne, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Recruiting
      • Oklahoma Heart Hospital South
      • Contact: Paul Garabelli, MD
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Recruiting
      • Doylestown Hospital
      • Contact: John Harding, MD
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Recruiting
      • Erlanger Medical Center
      • Contact: Harish Manyam, MD
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Centennial Medical Center
      • Contact: Gregory Bashian, MD
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Methodist Hospital of San Antonio
      • Contact: David Pederson, MD
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Active, not recruiting
      • St. Marks Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital
      • Contact: Venkat Iyer, MD
    • Richmond, Virginia, United States, 23225
      • Recruiting
      • Chippenham Hospital
      • Contact: Saumil Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment group; Single arm group to receive ablation

Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kristin Ruffner, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Tachycardia
• Other Study ID Numbers: ABT-CIP-10436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes