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
About this trial
This is an interventional treatment trial for Symptomatic Supraventricular Tachycardia
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
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
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
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As Low As Reasonable Achievable Fluoroscopy for SVT Ablation
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