Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal<br>Supraventricular Tachycardias: a randomized controlled trial

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:;* Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT: palpitations associated with narrow-complex tachycardia (* 1 episode) documented by a 12-lead electrogram, Holter monitoring, transtelephonic event recorder, telemetry strip or implanted device (implantable loop recorder, pacemaker) within 12 months prior to referral to EPS; or frequent symptoms of palpitation (within 12 months prior to referral) associated with clinical signs highly suggestive of PSVT: 1, sudden onset and termination of rapid (and regular) palpitations usually accompanied with neck pulsation and/or dizziness, 2, termination with Valsalva maneuver or carotid sinus massage and 3, no evidence for an underlying structural heart disease.
* Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study.
* Verbal consent to continue with ablation therapy after the diagnostic steps of the EPS identified the above mentioned arrhythmia mechanisms, and after the patient received sufficient information about the benefits and potential risks of the ablative treatment of the individual arrhythmia substrate.
* Informed written consent to being included in the study.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. evidence of structural heart disease and/or myocardial ischemia*
2. pregnancy (and lack of exclusion of potential pregnancy)
3. age below 18 years
* as revealed by the medical history or diagnosed by either of the following modalities: echocardiography, (exercise) electrocardiogram, myocardial perfusion scan, coronary angiography, coronary CT-angiography or magnetic resonance imaging.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number and duration of radiofrequency application during the ablation<br /><br>procedures of paroxysmal supraventricular tachycardia (AVNRT and WPW-AVRT). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the followings:<br /><br><br /><br>1. long-term procedural success: Free from recurrence of pre-excitation or the<br /><br>same clinical type of paroxysmal supraventricular tachycardia (AVNRT or AVRT)<br /><br>at 12 months after the ablation procedure, as evidenced by 12-lead<br /><br>electrocardiogram, Holter registration, or implanted device (implantable loop<br /><br>recorder, pacemaker).<br /><br>2. acute procedural success: non-inducibility of clinical arrhythmia verified<br /><br>at the end of the standard EP study.<br /><br>3. fluoroscopy time<br /><br>4. total procedural duration<br /><br>5. (serious) adverse events<br /><br>6. time to recurrence of AVNRT/AVRT</p><br>