Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-08-31

Brief Summary

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A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation.

The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.

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Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryoballoon ablation

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.

Group Type ACTIVE_COMPARATOR

Cryoballoon ablation

Intervention Type PROCEDURE

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.

Radiofrequency Ablation

Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type PROCEDURE

Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.

Interventions

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Radiofrequency Ablation

Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.

Intervention Type PROCEDURE

Cryoballoon ablation

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.

Intervention Type PROCEDURE

Other Intervention Names

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Pulmonary vein isolation Pulmonary vein isolation

Eligibility Criteria

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Inclusion Criteria

1. Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
2. Patients presenting with Persistent AF with AF duration \< 2 years scheduled to undergo a PVAI procedure
3. Age range of 18 - 85 years
4. Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
5. Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria

* Congenital heart disease, age younger than 18 years, significant valve disease, LA size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or New York Heart Association class IV).
* Presence of a mechanical prosthetic valve.
* Secondary causes of atrial fibrillation
* Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
* Social factors that would preclude follow up or make compliance difficult.-
* Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No