As Low As Reasonable Achievable Fluoroscopy for SVT Ablation

NCT02743325 | Completed

• 1 other identifier: 2015-142
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptomatic Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• recurrence of arrhythmia documented by ECGs

  Documentation by ECG,7-day-holter ECG, symptoms description by the patient

  within 90 days after the ablation procedure

Secondary Outcomes (4)

• total fluoroscopy time in minutes

  during the ablation procedure

• total radiation exposure in gy

  during the ablation procedure

• Duration of Ablation procedure in minutes

  skin to skin of the ablation procedure

• Composite adverse events

  within the first 30 days post ablation procedure

Study Arms (2)

ALARA protocol

ACTIVE COMPARATOR

SVT ablation by ALARA protocol

Procedure: SVT ablation by ALARA protocol

current treatment

ACTIVE COMPARATOR

SVT ablation by conventional protocol

Procedure: SVT ablation by conventional protocol

Interventions

SVT ablation by ALARA protocol PROCEDURE

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.

Also known as: radiofrequency ablation by ALARA protocol

ALARA protocol

SVT ablation by conventional protocol PROCEDURE

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.

Also known as: radiofrequency ablation by conventional protocol

current treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Richard Kobza: lead

Study Officials

• Richard Kobza, PD Dr. med.

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 19, 2016
• Study Start: April 25, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share