Remote MAGNetic Catheter Ablation for Atrial Fibrillation
Remote MAGNetic Catheter Ablation for Atrial Fibrillation
Prospective observational single center trial, evaluating the safety, radiation exposure and
 efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.
Background: Since the first description in 1998 catheter-interventional ablation (CA) has
 evolved to a standard treatment for symptomatic drug-refractory atrial fibrillation (AF).

 Ablation efficacy but also complication percentage and radiation exposure are influenced by
 several factors, among them patient age, body weight, type and duration of AF, underling
 cardiac disease as well as the used ablation method, technology and the experience of the
 operator.

 The objectives of developing a system for remote magnetic catheter navigation (RMN) were to
 improve the efficacy and safety of complex ablation procedures and to reduce radiation
 exposure. However, convincing data supporting this theory are still lacking.

 Aim: To evaluate efficacy, safety profile / complication rate and radiation exposure in
 serial ablation procedures for paroxysmal and persistent AF as well as repeat interventions
 based on remote magnetic navigation and 3-D image integration with assessment of the learning
 curve for this complex technology.

 Design: single center observational registry, analytical questioning, non-randomized,
 non-controlled, not blinded, consecutive patient inclusion

 Study population:

 Inclusion criteria: Consecutive patients with class I or class IIa indication for CA for
 symptomatic atrial fibrillation according to the current guidelines.

 Exclusion criteria:

 -  Contraindication for AF catheter ablation

 -  Contraindication for RMN procedure. (These patients may undergo AF ablation with another
 technology, e.g. cryo-balloon ablation).

 -  Age < 18 years, gravidity

 Endpoints Primary endpoint

 Safety:

 -  The number of peri-procedural major complications.

 -  Adverse events are classified according to the 2012 Expert consensus statement on
 catheter and surgical ablation of AF [Calkins H et al. 2012 HRS/EHRA/ECAS Expert
 Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Europace
 (2012) 14, 528-606 doi:10.1093/europace/eus027].

 Secondary endpoints Efficacy

 -  Acute: number of successfully isolated pulmonary veins.

 -  Mid-term: freedom from any atrial tachyarrhythmia (atrial fibrillation/atypical atrial
 flutter/atrial tachycardia; duration > 30 sec) after 6 months follow-up (initial
 blanking period of 3 months).

 -  Long-term:

 -  Freedom from any atrial tachyarrhythmia (duration > 30 sec) after 12 months follow-up
 (initial blanking period of 3 months).

 -  Time to first recurrence of an atrial tachyarrhythmia after an initial blanking period
 of 3 months.

 Radiation exposure:

 -  mean effective dose (ED), based on the measured dose-area-product. Aim is to show the
 potential of RMN to reduce the mean ED below 1.5 mSv in daily routine RMN AF ablation
 procedures

 -  The fluoroscopy parameters are documented for system calibration (A), transseptal
 access/catheter positioning (B), mapping/ablation (C).

 Safety:

 -  Number of peri-procedural minor complications

 -  Number of all procedure-related complications during 12 months follow-up.

 Subgroups:

 -  Type of AF (paroxysmal versus non-paroxysmal)

 -  Type of antiarrhythmic drug treatment (AAD)

 -  Demonstration of low-voltage areas / fibrosis

 -  Ablation: only pulmonary vein antral isolation (PVAI) versus additional substrate
 modification / box isolation of fibrotic areas (BIFA)

 -  Adipositas (BMI ≥ 30 kg/m²)

 -  Transseptal access after puncture versus via patent foramen ovale

 -  First ablation versus repeat procedure

 Randomisation: none

 Study procedure:

 Pre-ablation: screening of all patients, referred for catheter ablation for AF. Inclusion
 after given informed consent. Oral anticoagulation (OAC) for at least 3 weeks.
 Transesophageal echocardiography (TEE) in all patients.

 Ablation: Non-interrupted OAC, non-vitamin-K antagonist treatment withheld only the morning
 before ablation. All patients undergo PVAI and mapping for fibrotic areas, additional
 substrate modification on decision of the operator.

 Techniques and technologies used: RMN: Niobe/Epoch®, Navigant™, 0.1 Tesla, Stereotaxis Inc.;
 fluoroscopy system: Siemens AXIOM-Artis VC12B, 6-1 fps; non-fluoroscopic mapping (NFM):
 Carto-RMT, magnetic resonance-image-integration, (Biosense-Webster Inc.); TEE-guided single
 transseptal puncture, "Single catheter ablation" technique: Navistar-RMT Thermocool
 (Biosense-Webster Inc.), target temperature 48°C, power limit 40Watts (posterior left atrial
 wall) up to 50W, irrigation infusion rate 17 mL/min; Heparin for maintaining an activated
 clotting time between 300 to 400 sec. Endpoint: bidirectional PV-block.

 Post-ablation in hospital: OAC continued immediately following sheath removal after ablation
 for a minimum of 2 months, thereafter according to embolic risk (CHA2DS2-VASc-risk
 evaluation). 48 hours telemonitoring, echocardiography.

 Follow up: blanking period 3 months. Clinical evaluation after 3, 6 and 12 months including
 echocardiography and 72-hours Holter.

 Unscheduled visits for complications and symptoms suggesting recurrent tachyarrhythmia.
Inclusion Criteria:

 -  Consecutive patients with class I or class IIa indication for catheter ablation for
 symptomatic atrial fibrillation according to the current guidelines.

 Exclusion Criteria:

 -  Contraindication for AF catheter ablation

 -  Contraindication for magnetically guided ablation procedure

 -  Age < 18 years, gravidity, breast feeding