Clinical trial NCT02074566: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Official title: A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Pulmonary Vein Isolation
Atrial fibrillation
Cryoballoon therapy
Duration
Lead sponsor: Thorax Centrum Twente
Sponsor class: OTHER
Collaborators: name: Thorax Centrum Twente
name: Academisch Ziekenhuis Maastricht
First posted: 2014-02-28
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

Detailed description: Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.

Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

Study design The study is designed as a prospective multicentre randomized efficacy study.

Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.

Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".

Main study parameters/endpoints Acute success of pulmonary vein isolation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
* Age \< 70 years.
* Willing and able to sign informed consent.
* Willing to and capable of following the requested study procedures.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy
* Life or follow-up expectancy \< 12 months.
* Previous PVI.
* Contrast allergy.
* Creatin clearance level \< 60.
* Left ventricular ejection fraction \< 40%
* Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter \>50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or \>40 cc/m2 . This will lead to exclusion after inclusion but before randomisation.

Primary outcomes:
measure: Number of patients wit successfull pulmonary vein isolation
timeFrame: up to 6 minutes
Secondary outcomes:
measure: Number of complications
timeFrame: 1 year
measure: Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present
timeFrame: up to 6 minutes
measure: Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation
timeFrame: up to 6 minutes
measure: Procedure time, fluoroscopy time, amount of contrast used
timeFrame: up to 6 minutes
measure: Lower Esophageal Temperature development
timeFrame: up to 6 minutes
measure: Atrial Fibrillation recurrence
timeFrame: after 1 year follow up
measure: Balloon temperatures measured by the console
timeFrame: up to 6 minutes
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Nederland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References: