TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

NCT ID: NCT03354663

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-11
• Study Completion Date: 2019-10-30

Brief Summary

This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). 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 in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.

Detailed Description

This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TactiCath SE

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

Group Type: EXPERIMENTAL

TactiCath SE

Intervention Type: DEVICE

Ablation to achieve pulmonary vein isolation.

Interventions

TactiCath SE

Ablation to achieve pulmonary vein isolation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug
• Physician's note indicating recurrent self-terminating AF
• One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure
• At least 18 years of age
• Able and willing to comply with all trial requirements
• Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Exclusion Criteria

• Persistent or long-standing persistent atrial fibrillation (AF)
• Four or more cardioversions in the past 12 months
• Active systemic infection
• Known presence of cardiac thrombus
• Implanted with implantable cardiac defibrillator (ICD)
• Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
• Left atrial diameter > 5.0 cm
• Left ventricular ejection fraction < 35%
• New York Heart Association (NYHA) class III or IV
• Previous left atrial surgical or catheter ablation procedure
• Left atrial surgical procedure or incision with resulting scar
• Previous tricuspid or mitral valve replacement or repair
• Heart disease in which corrective surgery is anticipated within 6 months
• Bleeding diathesis or suspected procoagulant state
• Contraindication to long term antithromboembolic therapy
• Presence of any condition that precludes appropriate vascular access
• Renal failure requiring dialysis
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Pregnant or nursing
• Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
• Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
• Patient is unlikely to survive the protocol follow up period of 12 months
• Body mass index > 40 kg/m2
• Vulnerable subject

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Ruffner, PhD MBA

Role: STUDY_DIRECTOR

Abbott

Locations

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Scripps Health

La Jolla, California, United States

Sequoia Hospital

Redwood City, California, United States

South Denver Cardiology Associates, P.C.

Littleton, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Florida Hospital

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Mayo Clinic

Rochester, Minnesota, United States

New York University Hospital

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

Ashford Hospital

Adelaide, , Australia

Royal Adelaide Hospital

Adelaide, , Australia

Royal Melbourne Hospital - City Campus

Melbourne, , Australia

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Ospedale San Raffaele

Milan, Lombardy, Italy

Centro Cardiologico Monzino

Milan, , Italy

Countries

United States; Australia; Germany; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10216

Identifier Type: -

Identifier Source: org_study_id