NCT03044951

Brief Summary

It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

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
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3.6 years

First QC Date

January 30, 2017

Last Update Submit

February 6, 2017

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcryoablationirrigated radiofrequency ablationpulmonary vein isolation

Outcome Measures

Primary Outcomes (2)

  • Efficacy endpoint (time to first documented clinical recurrence after blanking period)

    the time to first documented clinical recurrence after blanking period (month)

    one year

  • Safety endpoint (Any procedure-related complications)

    Any procedure-related complications

    one year

Secondary Outcomes (5)

  • Procedure time (min)

    one year

  • Left atrial time (min)

    one year

  • X-ray time (min)

    one year

  • time to first time cardiovascular hospitalization (month)

    one year

  • QoL changes at 12 months (Units on a Scale)

    one year

Study Arms (2)

cryoballoon ablation

EXPERIMENTAL

patients who accept cryoballoon ablation

Procedure: cryoballoon ablation

radiofrequency ablation

ACTIVE COMPARATOR

patients who accept radiofrequency ablation

Procedure: radiofrequency ablation

Interventions

cryoballoon ablationPROCEDURE

cryoballoon ablation：pulmonary vein isolation by cryoballoon

cryoballoon ablation
radiofrequency ablationPROCEDURE

radiofrequency ablation: pulmonary vein isolation by radiofrequency energy

radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

  • ECG recording of atrial fibrillation
  • first time of ablation
  • refractory to at least one anti-arrhythmia drug
  • sign informed consent for participation in the study

You may not qualify if:

  • had ablation before
  • serious heart failure
  • left atrial diameter\>55mm
  • Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
  • Stroke in 6 months before the ablation
  • Endocardial thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • 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

  • Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.

    PMID: 24446022RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Li-Qun Wu

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Jin

CONTACT

jinqi127@163.com

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

June 1, 2020

Study Completion

December 1, 2020

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

CN(1)