NCT02587624

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

14.5 years

First QC Date

October 18, 2015

Last Update Submit

September 26, 2025

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablationremote magnetic navigation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Acute efficacy: number of successfully isolated pulmonary veins.

    Intra-procedural

  • Long-term efficacy: freedom from atrial tachyarrhythmia.

    12 months

  • Long-term efficacy: time to recurrence of atrial tachyarrhythmia.

    12 months

  • Safety: radiation exposure.

    Peri-procedural (from the beginning of the procedure until sheath removal)

  • Safety: peri-procedural minor complications.

    Peri-procedural (from the beginning of the procedure until 48 hours after sheath removal)

  • +1 more secondary outcomes

Other Outcomes (4)

  • Efficacy: freedom from atrial tachyarrhythmia in pre-specified patient subgroups.

    12 months

  • Efficacy: time to first recurrence of atrial tachyarrhythmia in pre-specified patient subgroups.

    12 months

  • Safety: procedure related complications in pre-specified subgroups during long term follow-up.

    12 months

  • +1 more other outcomes

Study Arms (1)

RMN AF ablation

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

Procedure: catheter ablation

Interventions

catheter ablationPROCEDURE

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.

RMN AF ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with class I or class IIa indication for catheter ablation for symptomatic atrial fibrillation according to the current guidelines \[Camm AJ et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation. European Heart Journal (2012) 33, 2719-2747\].

You may qualify if:

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

You may not qualify if:

  • Contraindication for AF catheter ablation
  • Contraindication for magnetically guided ablation procedure
  • Age \< 18 years, gravidity, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paracelsus Medical University, Klinikum Nürnberg

Nuremberg, Bavaria, 90471, Germany

Location

Related Publications (1)

  • Bastian D, Schwab J, Steurer KT, Brinker-Paschke A, Boessenecker A, Doering R, Karakurt Z, Vitali-Serdoz L, Pauschinger M, Gohl K. Oesophageal injury following magnetically guided single-catheter ablation for atrial fibrillation: insights from the MAGNA-AF registry. Europace. 2018 May 1;20(suppl_2):ii48-ii55. doi: 10.1093/europace/euy021.

    PMID: 29722860BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Dirk Bastian, MD

    Klinikum Fuerth, Fuerth

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 18, 2015

First Posted

October 27, 2015

Study Start

March 1, 2011

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

DE(1)