Clinical Research Directory

Atrial Flutter Ablation in the iCMR

The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

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.

Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)

A randomized controlled trial will be conducted to evaluate the efficacy of Ablation Index-guided high power - short duration (HPSD) ablation compared to conventional power settings in Cavotricuspid Isthmus (CTI) dependent atrial flutter. Participants will be randomized to receive either AI-guided HPSD ablation at 50 Watts or conventional power settings at 30 Watts. Both arms will use the Carto 3D mapping system and the QDOT MICRO ablation catheter (Biosense Webster). An anatomically contiguous line will be created with \<6mm inter-lesion distance. After a standardized wait time of 30 minutes, ablation success will be assessed. The primary outcome is total radiofrequency ablation time. Secondary outcomes include procedural time, fluoroscopy time, safety outcomes, and 3-month freedom from recurrence. It is our expectation that HPSD will result in a shorter primary outcome.