MedDataX Logo

Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy

NCT ID: NCT01920295

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paroxysmal Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cryoballoon ablation

Cryoballoon ablation

Group Type EXPERIMENTAL

Cryoballoon ablation

Intervention Type DEVICE

Cryoballoon after medical therapy

Cryoballoon ablation

Group Type ACTIVE_COMPARATOR

Cryoballoon ablation

Intervention Type DEVICE

Cryoballoon as first-line therapy

Cryoballoon ablation

Group Type EXPERIMENTAL

Cryoballoon ablation

Intervention Type DEVICE

Cryoballoon after failed drug therapy

Cryoballoon ablation

Group Type ACTIVE_COMPARATOR

Cryoballoon ablation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryoballoon ablation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria

* atrial fibrillation other than PAF, asymptomatic, previous AF ablation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yuksek Ihtisas Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Serkan Cay

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yuksek Ihtisas Heart-Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3196568

Identifier Type: -

Identifier Source: org_study_id