Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

NCT03650556 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10239
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 22

Brief Summary

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Rate of Subjects With a Device and/or Procedure-related SAE.

  Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.

  Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure

• Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.

  The following events were considered a failure for AF/AFL/AT recurrence: * If AF/AFL/AT recurrence (\>30 second episode) occurred at any time after the therapy consolidation period (\>180 days after the initial procedure), or * If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \>30 second AF/AFL/AT episode, or * If the subject required a second repeat procedure at any time after the initial procedure, or * If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or * If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or * If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the

  15 months

Secondary Outcomes (3)

• Acute Procedural Success

  Immediate post procedure

• 15-month Success Off of Antiarrhythmic Drugs

  15 months

• 15 Month Single Procedure Success

  15 months

Study Arms (1)

Ablation

EXPERIMENTAL

Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).

Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Interventions

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ DEVICE

Ablation procedure for Persistent AF

Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 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 (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
• Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
• Age 18 years or older
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if:

• 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
• Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
• CABG surgery within the 6-months (180-days) prior to the initial procedure
• Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
• Any carotid stenting or endarterectomy
• Documented or known left atrial thrombus on imaging
• Left atrial diameter \> 50 mm (parasternal long axis view or by CT)
• Left ventricular ejection fraction \< 40%
• Unable to take anticoagulation medication due to contraindication or intolerance
• History of blood clotting or bleeding abnormalities
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
• Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure
• Rheumatic heart disease
• Uncontrolled heart failure or NYHA functional class III or IV

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (22)

University Hospital (UAB)

Birmingham, Alabama, 35249, United States

Location

St. Bernards

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hosptial

Little Rock, Arkansas, 72211, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

South Denver Cardiology Associates

Littleton, Colorado, 80120, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University Hosptial

Atlanta, Georgia, 30322, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital - City Campus

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Amber Miller
• Organization: Abbott Medical

amber.miller@abbott.com

(612) 413-7236

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 28, 2018
• Study Start: September 28, 2018
• Primary Completion: December 21, 2020
• Study Completion: January 11, 2021
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (20)