NCT03053570

Brief Summary

The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 31, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 31, 2017

Last Update Submit

February 12, 2017

Conditions

Persistent Atrial Fibrillation

Keywords

CryoballoonContact ForcePersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with successful Pulmonary Vein Isolation

    in one year

Study Arms (2)

Cryoballoon

EXPERIMENTAL
Device: CryoballoonDevice: Radiofrequency Energy(Contact Force)

Radiofrequency Energy(Contact Force)

EXPERIMENTAL
Device: CryoballoonDevice: Radiofrequency Energy(Contact Force)

Interventions

CryoballoonDEVICE

use Cryoballoon to isolation the Pulmonary Vein

CryoballoonRadiofrequency Energy(Contact Force)
Radiofrequency Energy(Contact Force)DEVICE

use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

CryoballoonRadiofrequency Energy(Contact Force)

Eligibility Criteria

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

You may qualify if:

  • persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.

You may not qualify if:

  • Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Baopeng Tang

    First Affiliated Hospital of Xinjiang Medical University

    STUDY CHAIR

Central Study Contacts

Baopeng Tang, PhD

CONTACT

+86 13579881111tangbaopeng1111@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 15, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

CN(1)