NCT04678258 Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation
| NCT ID | NCT04678258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klinikum-Fuerth |
| Condition | Catheter Ablation |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2020-11-30 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2020-11-30 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Dirk Bastian, MD
PRINCIPAL INVESTIGATOR
Klinikum-Fuerth
Frequently Asked Questions
Who can join the NCT04678258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Catheter Ablation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04678258 currently recruiting?
Yes, NCT04678258 is actively recruiting participants. Contact the research team at dirk.bastian@klinikum-fuerth.de for enrollment information.
Where is the NCT04678258 trial being conducted?
This trial is being conducted at Fürth, Germany.
Who is sponsoring the NCT04678258 clinical trial?
NCT04678258 is sponsored by Klinikum-Fuerth. The principal investigator is Dirk Bastian, MD at Klinikum-Fuerth. The trial plans to enroll 106 participants.