TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

NCT02310100 | Completed Results

• 1 other identifier: SJM-CIP-10030
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 20

Brief Summary

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)

  Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.

  12 Months post ablation

• Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event

  The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.

  7 days

Study Arms (1)

TactiCath Quartz

EXPERIMENTAL

TactiCath Quartz treatment

Device: TactiCath Quartz treatment

Interventions

TactiCath Quartz treatment DEVICE

TactiCath Quartz

Eligibility Criteria

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

You may qualify if:

• Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug
• Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device
• Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
• Patient is 18 years of age or older
• Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
• Patient provides written informed consent prior to enrollment in the study

You may not qualify if:

• Persistent or long-standing persistent atrial fibrillation (AF)
• Patient has had 4 or more cardioversions in the past 12 months.
• Active systemic infection
• Presence of 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 ablation procedure, either surgical or catheter ablation
• Patient has had a 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 pro coagulant state
• Contraindication to long term antithromboembolic therapy

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Glendale Memorial Hospital and Health Center

Glendale, California, 91204, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Cardiology Consultants of East Michigan

Flint, Michigan, 48532, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78704, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

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: Lori Rusch, Ph.D.
• Organization: Abbott

lori.rusch@abbott.com

1-651-756-2668

Study Officials

• Kristin Ruffner, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

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: December 3, 2014
• First Posted: December 5, 2014
• Study Start: January 21, 2015
• Primary Completion: February 1, 2017
• Study Completion: September 17, 2021
• Last Updated: October 12, 2021
• Results First Posted: March 28, 2019

Record last verified: 2021-09

Locations

US (20)