TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

NCT03354663 | Completed Results FDA Device

• 1 other identifier: SJM-CIP-10216
• Study Type: interventional
• Target: 156
• Locations: 4 countries
• Sites: 21

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillation; PAF; ablation

Outcome Measures

Primary Outcomes (2)

• Rate of Serious Adverse Events

  The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.

  30 days

• Number of Participants With Procedural Success

  The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins

  0 days

Other Outcomes (19)

• Average Power Delivered

  During Procedure

• Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force

  0 days

• Number of Participants Experiencing Serious Adverse Events Within 30 Days

  30 days

Study Arms (1)

TactiCath SE

EXPERIMENTAL

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

Device: TactiCath SE

Interventions

TactiCath SE DEVICE

Ablation to achieve pulmonary vein isolation.

TactiCath SE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (21)

Arkansas Heart Hospital

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, P.C.

Littleton, Colorado, 80120, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, 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

Ashford Hospital

Adelaide, 5000, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Royal Melbourne Hospital - City Campus

Melbourne, 3050, Australia

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 01307, Germany

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

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: Steven Madej
• Organization: Abbott

steven.madej@abbott.com

651-756-2230

Study Officials

• Kristin Ruffner, PhD MBA

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: November 17, 2017
• First Posted: November 28, 2017
• Study Start: December 11, 2017
• Primary Completion: August 2, 2018
• Study Completion: October 30, 2019
• Last Updated: October 11, 2023
• Results First Posted: August 20, 2019

Record last verified: 2023-10

Locations

IT (2); DE (2); AU (3); US (14)