NCT03044925

Brief Summary

Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Status
unknown

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

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

January 30, 2017

Last Update Submit

September 5, 2019

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillationremote magnetic navigationcryoablation

Outcome Measures

Primary Outcomes (2)

  • Clinical efficacy (time to first AF recurrence after blanking period)

    the time to first AF recurrence after blanking period (month)

    one year

  • Clinical safety (Any procedure-related complications)

    Any procedure-related complications

    one year

Secondary Outcomes (4)

  • Procedure time (min)

    one week

  • Time to first cardiovascular hospitalization (month)

    one year

  • QoL of 12 months (Units on a Scale)

    one year

  • X-ray time (min)

    one week

Study Arms (2)

Remote magnetic navigation

EXPERIMENTAL

Persistent atrial fibrillation ablation with remote magnetic navigation

Procedure: Remote magnetic navigation

Cryoablation

ACTIVE COMPARATOR

Persistent atrial fibrillation ablation with cryoballoon

Procedure: Cryoablation

Interventions

Remote magnetic navigationPROCEDURE

Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation

Remote magnetic navigation
CryoablationPROCEDURE

Pulmonary vein isolation and other areas ablation used by cryoballoon

Cryoablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent atrial fibrillation (\>7d, \< 5years)
  • Age 18-75 years
  • Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol

You may not qualify if:

  • Any previous left atrial ablation or surgery
  • Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
  • Stroke or transient ischemic attack within 6 months prior to enrollment
  • Myocardial infarction within 3 months prior to enrollment
  • Anteroposterior left atrial diameter \> 55 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

    PMID: 27042964RESULT

  • Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.

    PMID: 27381589RESULT

  • Kuniss M, Greiss H, Pajitnev D, Akkaya E, Deubner N, Hain A, Bodammer L, Berkowitsch A, Chierchia GB, Hamm CW, Neumann T. Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduction block in addition to antral pulmonary vein isolation. Europace. 2017 Jul 1;19(7):1109-1115. doi: 10.1093/europace/euw146.

    PMID: 27738068RESULT

  • Jin QI, Pehrson S, Jacobsen PK, Chen XU. Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures. J Cardiovasc Electrophysiol. 2016 Mar;27 Suppl 1:S23-8. doi: 10.1111/jce.12929.

    PMID: 26969219RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Qi Jin, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 7, 2017

Study Start

November 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share