NCT01920295

Brief Summary

Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

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

January 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

2.2 years

First QC Date

May 1, 2013

Last Update Submit

August 7, 2013

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

  • Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

    At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring

    12 months from the procedure

  • Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

    At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring

    3 months from the procedure

  • Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

    At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring

    6 months from the procedure

  • Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

    At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring

    9 months from the procedure

Study Arms (4)

Cryoballoon ablation

EXPERIMENTAL

Cryoballoon ablation

Device: Cryoballoon ablation

Cryoballoon after medical therapy

ACTIVE COMPARATOR

Cryoballoon ablation

Device: Cryoballoon ablation

Cryoballoon as first-line therapy

EXPERIMENTAL

Cryoballoon ablation

Device: Cryoballoon ablation

Cryoballoon after failed drug therapy

ACTIVE COMPARATOR

Cryoballoon ablation

Device: Cryoballoon ablation

Interventions

Cryoballoon ablationDEVICE
Cryoballoon ablationCryoballoon after failed drug therapyCryoballoon after medical therapyCryoballoon as first-line therapy

Eligibility Criteria

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

You may qualify if:

  • paroxysmal atrial fibrillation, symptomatic

You may not qualify if:

  • atrial fibrillation other than PAF, asymptomatic, previous AF ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas Heart-Education and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Associate Professor

Study Record Dates

First Submitted

May 1, 2013

First Posted

August 9, 2013

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

TU(1)