TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (TactiSense)

Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: TactiCath SE

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Adelaide, Australia, 5000
    • Ashford Hospital
  • Melbourne, Australia, 3050
    • Royal Melbourne Hospital - City Campus
• Germany
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Herzzentrum Leipzig GmbH
• Italy
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
    • Redwood City, California, United States, 94062
      • Sequoia Hospital
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, P.C.
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TactiCath SE; Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.	Device: TactiCath SE; Ablation to achieve pulmonary vein isolation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Power Delivered	This outcome is the average power delivered for a case.	During Procedure
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force	Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force	0 days
Number of Participants Experiencing Serious Adverse Events Within 30 Days	Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.	30 days
Number of Participants Experiencing a Serious Adverse Event Within 1 Year	Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation	1 year
One-year Freedom From AF	One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.	1 year
One-year Drug-free Success From AF	One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.	1 year
Changes in EQ-5D-5L Utility Scores	Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.	1 year
Changes in AFEQT Scores	Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.	1 year
Health Care Utilization	Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.	1 year
Force Time Integral (FTI)	Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.	0 days
Average Catheter Temperature	This outcome is the average temperature (by lesion) for a case.	0 days
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure	This outcome is whether or not the recommended irrigation flow rate was used for a case.	0 days
Contact Force During Procedure	This outcome is the average contact force for a case.	0 days
Total Procedure Time	This outcome is the total procedure time for a case.	0 days
Ablation Time - First to Last Ablation	This outcome is the total ablation time for a case. This is the time from first to last ablation.	0 Days
Fluoroscopy Time	This outcome is the total fluoroscopy time for a case.	0 days
Radiofrequency (RF) Application Time	This outcome is the total RF application time for a case.	0 days
Number of Participants Using AutoMark	This outcome is the number of cases using AutoMark.	0 days
Lesion Index (LSI)	Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.	0 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ablation; paroxysmal atrial fibrillation; PAF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SJM-CIP-10216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes