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Search / Trial NCT04678258

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

Launched by KLINIKUM-FUERTH · Dec 18, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Atrial Flutter Typical Catheter Ablation Electroanatomic Mapping

ClinConnect Summary

This clinical trial is studying two different methods for treating a heart condition called typical atrial flutter, which can be caused by abnormal electrical signals in the heart. The trial compares a newer approach called zero-fluoroscopy voltage-guided ablation, which uses advanced technology to minimize radiation exposure, against the traditional linear ablation method. The goal is to see if the new method can be just as effective while being safer for patients.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of typical atrial flutter that has been confirmed by a heart test called an ECG. You should also meet certain health criteria that allow for the procedure. Participants will undergo the ablation treatment and will be monitored closely during and after the procedure to assess its effectiveness. This study has been approved by an ethics committee, ensuring that it follows strict guidelines to protect patient safety.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Klinikum Fuerth

Klinikum Fürth is a leading healthcare institution dedicated to advancing medical research and patient care. As a prominent clinical trial sponsor, it focuses on innovative therapies and treatments, fostering collaborations with academic and industry partners to enhance clinical outcomes. With a commitment to rigorous scientific standards and ethical practices, Klinikum Fürth plays a vital role in the development of novel interventions that address unmet medical needs, ultimately contributing to the improvement of health and quality of life for diverse patient populations.

Locations

Fuerth, Bavaria, Germany

Patients applied

0 patients applied

Trial Officials

Dirk Bastian, MD

Principal Investigator

Klinikum-Fuerth

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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