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TOCCATA - Touch+™ for Catheter Ablation (TOCCATA)

Primary Purpose

Atrial Fibrillation, Tachycardia, Supraventricular

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contact force assisted irrigated RF ablation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Supraventricular Tachycardia, Contact Force, RF Ablation, Radiofrequency, Pulmonary Vein Isolation, Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia [AVNRT], accessory pathway Wolff Parkinson White [WPW] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation

Exclusion Criteria:

  • Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery
  • Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart
  • Known cerebrovascular disease, including a history of stroke or transient ischemic attack
  • Left ventricular ejection fraction of <35%
  • Previous heart ablation procedure (surgical or catheter) to the target chamber

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Atrial Fibrillation

    Right-sided Supraventricular Tachycardia

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Operative and Post-operative Serious Adverse Events
    For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 2010
    Last Updated
    January 28, 2019
    Sponsor
    Abbott Medical Devices
    Collaborators
    Endosense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01223469
    Brief Title
    TOCCATA - Touch+™ for Catheter Ablation
    Acronym
    TOCCATA
    Official Title
    A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Devices
    Collaborators
    Endosense

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.
    Detailed Description
    Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure. Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations. Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Tachycardia, Supraventricular
    Keywords
    Atrial Fibrillation, Supraventricular Tachycardia, Contact Force, RF Ablation, Radiofrequency, Pulmonary Vein Isolation, Paroxysmal Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atrial Fibrillation
    Arm Type
    Experimental
    Arm Title
    Right-sided Supraventricular Tachycardia
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Contact force assisted irrigated RF ablation
    Other Intervention Name(s)
    TactiCath®, TactiSys®
    Intervention Description
    radiofrequency ablation of atrial fibrillation or SVT
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Operative and Post-operative Serious Adverse Events
    Description
    For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.
    Time Frame
    3 months for AF arm; 7 days for the right SVT arm

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia [AVNRT], accessory pathway Wolff Parkinson White [WPW] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation Exclusion Criteria: Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart Known cerebrovascular disease, including a history of stroke or transient ischemic attack Left ventricular ejection fraction of <35% Previous heart ablation procedure (surgical or catheter) to the target chamber
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karl-Heinz Kuck, Prof
    Organizational Affiliation
    Asklepios Klinik St. Georg, Hamburg, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22820056
    Citation
    Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.
    Results Reference
    result
    PubMed Identifier
    21872560
    Citation
    Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/22820056
    Description
    Reddy VY, et. al, The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study.Heart Rhythm. 2012 Nov;9(11):1789-95
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/21872560
    Description
    Kuck KH, et.al; A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23

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