Status:

RECRUITING

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

Lead Sponsor:

Klinikum-Fuerth

Collaborating Sponsors:

Boston Scientific Corporation

University of Trieste

Conditions:

Catheter Ablation

Atrial Flutter Typical

Eligibility:

All Genders

18+ years

Phase:

NA

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 convent...

Detailed Description

Rationale: Catheter ablation of the CTI represents the established curative first-line treatment for typical AFl. Although the acute and chronic efficacy is high, conventional ablation is still time ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

November 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT04678258

Start Date

November 30 2020

End Date

December 31 2026

Last Update

October 15 2024

Active Locations (1)

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1

Klinikum Fuerth

Fürth, Bavaria, Germany, 90766