Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKlinikum-Fuerth

About this trial

Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy.

Despite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial.

As a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue.

Objective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up.

The study has been approved by the responsible ethics committee.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG

Given class I indication for curative CTI ablation according to the current guidelines

Over 18 years old

Given informed consent

Disqualifiers

Any contraindication for CTI ablation

Previous CTI ablation

BCB as procedural endpoint not assessable

CTI ablation conducted in association with further ablation procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • HR electroanatomic mapping and MVG catheter ablation

    Procedure/Surgery

    High resolution CTI mapping using the mini-electrodes at the 8 mm catheter tip followed by voltage guided ablation

  • Conventional bipolar mapping and linear catheter ablation

    Procedure/Surgery

    Bipolar mapping and conventional anatomic linear catheter ablation

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Group 1: MVG ablationActive comparator 1 intervention
Group B: Group 2 - control: linear ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative ablation duration

Cumulative ablation duration (total radiofrequency (RF) energy delivery time) in seconds that is needed to achieve sustained complete CTI block (acute procedural efficacy)

Time frame
during procedure

Secondary outcomes

1

Number of RF ablation points, which are necessary to achieve CTI block

Total number of RF ablation points with minimal local energy-delivery of 20 seconds, which are necessary to achieve CTI block

Time frame
during procedure
2

Total amount of RF energy delivery for CTI block

Total amount of RF energy delivery for sustained CTI block (in kilo Joules)

Time frame
during procedure
3

Rate of procedure related adverse events

Safety: The rate of all procedure related adverse events will be documented and analyzed

Time frame
during procedure
4

Fluoroscopy time

The cumulative fluoroscopy duration (in minutes)

Time frame
during procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klinikum-Fuerth

Lead sponsor

Boston Scientific Corporation

Collaborator

University of Trieste

Collaborator