search
Back to results

As Low As Reasonable Achievable Fluoroscopy for SVT Ablation (ALARA-SVT)

Primary Purpose

Symptomatic Supraventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SVT ablation by ALARA protocol
SVT ablation by conventional protocol
Sponsored by
Richard Kobza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Supraventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with symptomatic SVT undergoing first SVT ablation procedure (and no prior history of cardiac surgery
  • Structurally normal heart (no major cardiac defects)

Exclusion Criteria:

  • Previous ablation for SVT (or cardiac surgery)
  • Contra-indications to catheter ablation therapy
  • Congenital heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ALARA protocol

    current treatment

    Arm Description

    SVT ablation by ALARA protocol

    SVT ablation by conventional protocol

    Outcomes

    Primary Outcome Measures

    recurrence of arrhythmia documented by ECGs
    Documentation by ECG,7-day-holter ECG, symptoms description by the patient

    Secondary Outcome Measures

    total fluoroscopy time in minutes
    fluoroscopy time measured in minutes administered during the Ablation procedure
    total radiation exposure in gy
    Exposition of the Patient to Radiation during the ablation procedure measured in gy
    Duration of Ablation procedure in minutes
    time needed to complete the procedure
    Composite adverse events
    Death of any cause, bleeding, vascular complications, and high-degree atrioventricular block

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    September 2, 2020
    Sponsor
    Richard Kobza
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02743325
    Brief Title
    As Low As Reasonable Achievable Fluoroscopy for SVT Ablation
    Acronym
    ALARA-SVT
    Official Title
    Optimisation of Catheter Navigation With As Low As Reasonable Achievable Fluoroscopy for Amelioration of Ablation Success in Patients With SupraVentricular Tachycardia (ALARA-SVT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 25, 2016 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Richard Kobza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Supraventricular tachycardia ablations of the Conformité Européenne (CE)-certified (since 2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) allows a seamless combination of a fluoro image and Carto® 3 System maps into a single view. This helps to reduce fluoroscopy levels and reduce exposure time for physicians, staff and patients to as low as reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the conventional radiofrequency Ablation.
    Detailed Description
    Aim of the current Randomized Clinical Study is to assess the safety and efficiency in supraventricular tachycardia ablations of the CE-certified (since 2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA), allowing a seamless combination of a fluoro Image and Carto® 3 System maps into a single view. It helps reduce fluoroscopy levels - consistent with the ALARA principle of reducing exposure for physicians, staff and patients to as low as reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the conventional radiofrequency (RF) ablation. Patients with symptomatic supraventricular tachycardia (SVT) will be included, more specifically patients with atrioventricular nodal re-entrant tachycardia (AVRNT), atrioventricular re-entrant tachycardia (AVRT) and typical atrial flutter (TAF). Current ablative treatment consists in destroying small areas of myocardial tissue or conduction system, or both, that are critical to the initiation or maintenance of the arrhythmia (slow pathway Ablation in the case of AVRNT, anomalous extra nodal connections between the atrium and ventricle along the atrioventricular groove in AVRT and cavo-tricuspid isthmus in the case of TAF). However, SVT ablations without a 3D navigation system have a certain fluoroscopy time and radiation exposure, respectively. Prolonged fluoroscopy and radiation exposure during ablation may potentially cause an increase in the lifetime risk of fatal malignancy. In a 1-year follow-up the arrhythmia recurrence rate without anti-arrhythmic drugs will be assessed using 7-day holter recording in 60 patients undergoing CartoUnivuTM guided SVT ablation (group A) vs. 60 patients undergoing conventional RF-catheter ablation (without CartoUnivuTM, group B). All patients will stop anti-arrhythmic drugs at least 1 week before the date of ablation. Each patient will undergo transthoracal echocardiography (TTE) before the intervention. In case transseptal is needed, heparin will be administered after successful transseptal puncture with an activated clotting time (ACT)-target ≥325 sec. Following data will be acquired: Age, gender, presence of structural heart disease (SHD), co-morbidities Duration of arrhythmia (first manifestation and longest lasting episode) Current and failed antiarrhythmic therapy Echocardiography: Dilatation, hypertrophy, regurgitation, Left ventricular ejection fracture (LVEF), any important other abnormalities (e.g. prolapse) Ablation for SVT: The following concept will be used for ablation of the slow pathway ablation in the case of AVRNT, anomalous extra nodal connections between the atrium and ventricle along the atrioventricular groove in AVRT and cavo-tricuspid isthmus in the case of TAF: Using the 3D-electro-anatomic system (CARTO3®) with the module for fluoroscopy integration (UnivuTM), the diagnostic catheters (10 poles deflectable catheter and fixed 4 poles catheter) will be introduced without using fluoroscopy after the registration phase and the transfer of a fluoroscopic image in anteroposterior (AP) and left anterior oblique (LAO) projections into the Carto3® System. Once the electrophysiology study is realized and the arrhythmia identified (an activation can be used for this purpose), the ablation catheter (Navistar® 4mm/8mm, Biosense Webster, Diamond Bar, USA) is then introduced (also without the use of fluoroscopy). In case no map was done for local activation time information, specific tags will be taken: AVRNT: His, coronary Sinus (CS) ostium AVRT right atrium: His, CS ostium, tricuspid annulus left atrium: left inferior vein, appendage, mitral annulus AF: His, ostium of the inferior vena cava, tricuspid annulus Aim of the ablation procedure is to ablate small areas of myocardial tissue or conduction system, or both, that are critical to the initiation or maintenance of the arrhythmia (slow pathway ablation in the case of AVRNT, anomalous extra nodal connections between the atrium and ventricle along the atrioventricular groove in AVRT and cavo-tricuspid isthmus in the case of TAF) using the CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) for fluoroscopy integration on the Carto 3® System, with no further arrhythmia inducibility. If a non-clinical arrhythmia corresponding to the patient symptoms is induced, pharmacological and/or electrical cardioversion in to sinus rhythm will be performed. If a coronariography is performed, the procedure time, fluoroscopy time and doses used will be discounted from the overall respective measurements. Annotation of ablation sites on the 3D-map must be performed only by the VisiTag algorithm (integrated in the CARTO3® system), which will allow post-procedural analysis of catheter stability at each RF delivery site, duration of RF-application values and catheter stability during ablation. The following procedural data will be acquired: Total procedure time (femoral vein puncture until removement of sheaths) Use of long sheath for ablation catheter (name and type, steerable or not) Duration of RF-delivery and mean delivered RF-power Fluoroscopy duration and doses Activation map: yes/no, how many points Complications Follow-up: Number of patients with arrhythmia recurrence after blanking period (3months post 1st ablation procedure and stop of antiarrhythmic drugs) 7-day holter for rhythm monitoring at 6 and 12 months Phone contact / questionnaire to document patients symptoms and medications after 6 and 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Supraventricular Tachycardia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    ALARA protocol
    Arm Type
    Active Comparator
    Arm Description
    SVT ablation by ALARA protocol
    Arm Title
    current treatment
    Arm Type
    Active Comparator
    Arm Description
    SVT ablation by conventional protocol
    Intervention Type
    Procedure
    Intervention Name(s)
    SVT ablation by ALARA protocol
    Other Intervention Name(s)
    radiofrequency ablation by ALARA protocol
    Intervention Description
    Catheter ablation is a procedure that uses radiofrequency energy (similar to microwave heat) to destroy a small area of heart tissue that is causing arrhythmias. Destroying this tissue helps restore your heart's regular rhythm. The usage of CartoUnivuTM allows a seamless combination of a fluoro image and Carto® 3 System maps into a single view.
    Intervention Type
    Procedure
    Intervention Name(s)
    SVT ablation by conventional protocol
    Other Intervention Name(s)
    radiofrequency ablation by conventional protocol
    Intervention Description
    Catheter ablation is a procedure that uses radiofrequency energy (similar to microwave heat) to destroy a small area of heart tissue that is causing arrhythmias. Destroying this tissue helps restore your heart's regular rhythm. The convention Ablation procedure works without a 3D navigation System.
    Primary Outcome Measure Information:
    Title
    recurrence of arrhythmia documented by ECGs
    Description
    Documentation by ECG,7-day-holter ECG, symptoms description by the patient
    Time Frame
    within 90 days after the ablation procedure
    Secondary Outcome Measure Information:
    Title
    total fluoroscopy time in minutes
    Description
    fluoroscopy time measured in minutes administered during the Ablation procedure
    Time Frame
    during the ablation procedure
    Title
    total radiation exposure in gy
    Description
    Exposition of the Patient to Radiation during the ablation procedure measured in gy
    Time Frame
    during the ablation procedure
    Title
    Duration of Ablation procedure in minutes
    Description
    time needed to complete the procedure
    Time Frame
    skin to skin of the ablation procedure
    Title
    Composite adverse events
    Description
    Death of any cause, bleeding, vascular complications, and high-degree atrioventricular block
    Time Frame
    within the first 30 days post ablation procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with symptomatic SVT undergoing first SVT ablation procedure (and no prior history of cardiac surgery Structurally normal heart (no major cardiac defects) Exclusion Criteria: Previous ablation for SVT (or cardiac surgery) Contra-indications to catheter ablation therapy Congenital heart disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Kobza, PD Dr. med.
    Organizational Affiliation
    Luzerner Kantonsspital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    As Low As Reasonable Achievable Fluoroscopy for SVT Ablation

    We'll reach out to this number within 24 hrs