Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02743325 |
| Other study ID # |
2015-142 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2016 |
| Est. completion date |
December 2018 |
Study information
| Verified date |
September 2020 |
| Source |
Luzerner Kantonsspital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
