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Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

NCT04678258 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-10-15

No results posted yet for this study

Summary

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.

Conditions

  • Catheter Ablation
  • Atrial Flutter Typical
  • Radiation Exposure

Interventions

PROCEDURE

HR electroanatomic mapping and MVG catheter ablation

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

PROCEDURE

Conventional bipolar mapping and linear catheter ablation

Bipolar mapping and conventional anatomic linear catheter ablation

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University of Trieste

    collaborator OTHER

  • Klinikum-Fuerth

    lead OTHER

Principal Investigators

  • Dirk Bastian, MD · Klinikum-Fuerth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678258 on ClinicalTrials.gov