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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074566
• Other study ID #: NL47337.044.13
• Status: Completed
• Phase: N/A
• Start date: August 14, 2014
• Est. completion date: February 13, 2019

Study information

• Verified date: April 2019
• Source: Thorax Centrum Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 13, 2019
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Cryoballoon ablation
PVI using cryoballoon

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	Nederland
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (3)

Lead Sponsor	Collaborator
Harald Verheij	Academisch Ziekenhuis Maastricht, Thorax Centrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients wit successfull pulmonary vein isolation	Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.	up to 6 minutes
Secondary	Number of complications	Complications being: Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation.; Temperatures reaching <12 C in the oesophagus during cryoablation.; Other complications such as delayed gastric emptying, pericardial fluid/tamponade, haemoptoe, vascular complications.	1 year
Secondary	Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present	The assessment of this outcome will take place during the procedure	up to 6 minutes
Secondary	Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation	The assessment of this outcome will take place during the procedure.	up to 6 minutes
Secondary	Procedure time, fluoroscopy time, amount of contrast used	The assessment of this outcome will take place right after the procedure. It measures procedural parameters.	up to 6 minutes
Secondary	Lower Esophageal Temperature development	The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.	up to 6 minutes
Secondary	Atrial Fibrillation recurrence		after 1 year follow up
Secondary	Balloon temperatures measured by the console		up to 6 minutes