Comparing two methods for catheter ablation of atrial flutter
A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial
NA · Klinikum-Fuerth · NCT04678258
This study is testing whether a new way of doing catheter ablation for atrial flutter can be safer and more effective than the standard method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinikum-Fuerth (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Fürth, Bavaria) |
| Trial ID | NCT04678258 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two approaches for catheter ablation of the cavo-tricuspid isthmus (CTI) in patients with typical atrial flutter. One method is the conventional linear ablation, while the other is a maximum voltage-guided (MVG) technique that targets high voltage areas to potentially reduce ablation duration and radiation exposure. The study aims to provide robust evidence on the efficacy and safety of the MVG approach compared to the standard method. Participants will undergo detailed mapping and signal analysis to identify the best treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with documented typical atrial flutter who are eligible for curative CTI ablation.
Not a fit: Patients with contraindications for CTI ablation, previous CTI ablation, or those with certain medical devices like pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more efficient treatment for patients with atrial flutter, reducing radiation exposure and procedural time.
How similar studies have performed: While there is growing evidence supporting the MVG approach, this study aims to provide the first properly powered prospective randomized trial to validate its efficacy compared to conventional methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fürth, Bavaria
- Klinikum Fuerth — Fürth, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Dirk Bastian, MD — Klinikum-Fuerth
- Study coordinator: Dirk Bastian, MD
- Email: dirk.bastian@klinikum-fuerth.de
- Phone: 7580 1101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Catheter Ablation, Atrial Flutter Typical, Radiation Exposure, atrial flutter typical, catheter ablation, electroanatomic mapping