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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354663
Recruitment Status : Completed
First Posted : November 28, 2017
Results First Posted : August 20, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 28, 2017
Results First Submitted Date  ICMJE August 1, 2019
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE December 11, 2017
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Rate of Serious Adverse Events [ Time Frame: 30 days ]
    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.
  • Number of Participants With Procedural Success [ Time Frame: 0 days ]
    The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2020)
  • Average Power Delivered [ Time Frame: During Procedure ]
    This outcome is the average power delivered for a case.
  • Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force [ Time Frame: 0 days ]
    Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
  • Number of Participants Experiencing Serious Adverse Events Within 30 Days [ Time Frame: 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.
  • Number of Participants Experiencing a Serious Adverse Event Within 1 Year [ Time Frame: 1 year ]
    Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
  • One-year Freedom From AF [ Time Frame: 1 year ]
    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.
  • One-year Drug-free Success From AF [ Time Frame: 1 year ]
    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.
  • Changes in EQ-5D-5L Scores [ Time Frame: 1 year ]
    Changes in EQ-5D-5L scores from baseline to follow up at 3, 6, and 12 months
  • Changes in AFEQT Scores [ Time Frame: 1 year ]
    Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months
  • Health Care Utilization [ Time Frame: 1 year ]
    Cardiovascular-related health care utilization through 12 months post index ablation
  • Force Time Integral (FTI) and Lesion Index (LSI) [ Time Frame: 0 days ]
    FTI and LSI will be derived from the available EnSite Precision data. Descriptive statistics will be generated for both variables.
  • Average Catheter Temperature [ Time Frame: 0 days ]
    This outcome is the average temperature (by lesion) for a case.
  • Number of Participants With Recommended Irrigation Flow Rate Used During Procedure [ Time Frame: 0 days ]
    This outcome is whether or not the recommended irrigation flow rate was used for a case.
  • Contact Force During Procedure [ Time Frame: 0 days ]
    This outcome is the average contact force for a case.
  • Total Procedure Time [ Time Frame: 0 days ]
    This outcome is the total procedure time for a case.
  • Ablation Time - First to Last Ablation [ Time Frame: 0 Days ]
    This outcome is the total ablation time for a case. This is the time from first to last ablation.
  • Fluoroscopy Time [ Time Frame: 0 days ]
    This outcome is the total fluoroscopy time for a case.
  • Radiofrequency (RF) Application Time [ Time Frame: 0 days ]
    This outcome is the total RF application time for a case.
  • Number of Participants Using AutoMark [ Time Frame: 0 days ]
    This outcome is the number of cases using AutoMark.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: TactiCath SE
Ablation to achieve pulmonary vein isolation.
Study Arms  ICMJE Experimental: TactiCath SE
Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.
Intervention: Device: TactiCath SE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
156
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 30, 2019
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354663
Other Study ID Numbers  ICMJE SJM-CIP-10216
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kristin Ruffner, PhD MBA Abbott
PRS Account Abbott Medical Devices
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP