Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

NCT04678258 | Recruiting

• 1 other identifier: Zero_Magic_KHF
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atrial flutter typical; catheter ablation; electroanatomic mapping

Outcome Measures

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)

  during procedure

Secondary Outcomes (6)

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

  during procedure

• Total amount of RF energy delivery for CTI block

  during procedure

• Rate of procedure related adverse events

  during procedure

• Fluoroscopy time

  during procedure

• Fluoroscopy exposure

  during procedure

Study Arms (2)

Group 1: MVG ablation

ACTIVE COMPARATOR

Group 1 - MVG: high-resolution mapping and maximum voltage guided stepwise CTI ablation (stepwise voltage guided approach (SVG)).

Procedure: HR electroanatomic mapping and MVG catheter ablation

Group 2 - control: linear ablation

ACTIVE COMPARATOR

Group 2 - control: conventional bipolar mapping and conventional linear CTI ablation.

Procedure: Conventional bipolar mapping and linear catheter ablation

Interventions

HR electroanatomic mapping and MVG catheter ablation PROCEDURE

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

Group 1: MVG ablation

Conventional bipolar mapping and linear catheter ablation PROCEDURE

Bipolar mapping and conventional anatomic linear catheter ablation

Group 2 - control: linear ablation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Any contraindication for CTI ablation
• Previous CTI ablation
• BCB as procedural endpoint not assessable
• CTI ablation conducted in association with further ablation procedures
• Patients with CIED (e.g. pacemaker, ICD)
• Tricuspid valve replacement
• Right atrial thrombus
• Pregnant or breastfeeding women
• Abuse of drugs or alcohol
• Age \< 18 years
• Incompliance to the treatment, e.g. necessary anticoagulation
• Expected survival less than one year
• Inability to understand the nature and rationale of the study
• Inability to take part in the follow up

Sponsors & Collaborators

• Klinikum-Fuerth: lead
• Boston Scientific Corporation: collaborator
• University of Trieste: collaborator

Study Sites (1)

Klinikum Fuerth

Fürth, Bavaria, 90766, Germany

RECRUITING

Study Officials

• Dirk Bastian, MD

  Klinikum-Fuerth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bastian, MD

CONTACT

7580 1101; dirk.bastian@klinikum-fuerth.de

Laura Vitali-Serdoz, MD

CONTACT

7580 1101; laura.vitali-serdoz@klinikum-fuerth.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded to the treatment group. During FU the physician is blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups, randomized

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: November 30, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)