Remote MAGNetic Catheter Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— MAGNA-AF  

Official title:

Safety, Radiation Exposure and Efficacy of Remote MAGNetic Catheter Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02587624
• Other study ID #: PMUN-DB-002-MAGNA-AF
• Status: Active, not recruiting
• Start date: March 2011
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective observational single center trial, evaluating the safety, radiation exposure and efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• catheter ablation
Intervention: All patients undergo magnetically guided pulmonary vein antral isolation and mapping for fibrotic areas. Procedural endpoint: bidirectional PV block. Additional substrate modification on decision of the operator.

Locations

Country	Name	City	State
Germany	Paracelsus Medical University, Klinikum Nürnberg	Nuremberg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bastian D, Schwab J, Steurer KT, Brinker-Paschke A, Boessenecker A, Doering R, Karakurt Z, Vitali-Serdoz L, Pauschinger M, Göhl K. Oesophageal injury following magnetically guided single-catheter ablation for atrial fibrillation: insights from the MAGNA-A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy: freedom from atrial tachyarrhythmia in pre-specified patient subgroups.	Freedom from any atrial tachyarrhythmia (AF/flutter/atrial tachycardia; duration > 30 sec, initial blanking period of 3 months) in different subgroups: Type of AF (paroxysmal versus non-paroxysmal); Type of antiarrhythmic drug treatment; 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	12 months
Other	Efficacy: time to first recurrence of atrial tachyarrhythmia in pre-specified patient subgroups.	Time to first recurrence of any atrial tachyarrhythmia (AF/flutter/atrial tachycardia; duration > 30 sec) after an initial blanking period of 3 months in different subgroups: Type of AF (paroxysmal versus non-paroxysmal); Type of antiarrhythmic drug treatment; 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	12 months
Other	Safety: procedure related complications in pre-specified subgroups during long term follow-up.	Number of procedure associated complications in different subgroups: Type of AF (paroxysmal versus non-paroxysmal); Type of antiarrhythmic drug treatment; 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	12 months
Other	Radiation exposure in pre-specified patient subgroups.	Procedural radiation exposure in different subgroups: Type of AF (paroxysmal versus non-paroxysmal); 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	Intra-procedural (duration of procedure)
Primary	Safety: peri-procedural major complications.	Procedure associated adverse events are classified according to the 2012 Expert consensus statement on catheter and surgical ablation of AF [Calkins et al, Europace 2012].	Peri-procedural (from the beginning of the procedure until 48 hours after sheath removal)
Secondary	Acute efficacy: number of successfully isolated pulmonary veins.	Number of successfully isolated pulmonary veins.	Intra-procedural
Secondary	Long-term efficacy: freedom from atrial tachyarrhythmia.	- Freedom from any atrial tachyarrhythmia (AF/flutter/atrial tachycardia; duration > 30 sec, initial blanking period of 3 months).	12 months
Secondary	Long-term efficacy: time to recurrence of atrial tachyarrhythmia.	- Time to first recurrence of any atrial tachyarrhythmia (AF/flutter/atrial tachycardia; duration > 30 sec) after an initial blanking period of 3 months	12 months
Secondary	Safety: 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).	Peri-procedural (from the beginning of the procedure until sheath removal)
Secondary	Safety: peri-procedural minor complications.	Procedure related adverse events are classified according to the 2012 Expert consensus statement on catheter and surgical ablation of AF [Calkins et al, Europace 2012].	Peri-procedural (from the beginning of the procedure until 48 hours after sheath removal)
Secondary	Safety: incidence of procedure related adverse events during long term follow-up.	Any complication during follow-up. Procedure related adverse events are classified according to the 2012 Expert consensus statement on catheter and surgical ablation of AF [Calkins et al, Europace 2012].	12 months