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

A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Cryoballoon ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Centre
  • Nederland
    • Enschede, Nederland, Netherlands, 7500 KA
      • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2 times 1; PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute	Other: Cryoballoon ablation; PVI using cryoballoon
Other: 2 times 2; PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes	Other: Cryoballoon ablation; PVI using cryoballoon
Other: 2 times 3; PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes	Other: Cryoballoon ablation; PVI using cryoballoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Atrial Fibrillation recurrence		after 1 year follow up
Balloon temperatures measured by the console		up to 6 minutes

Collaborators and Investigators

• Sponsor: Harald Verheij
• Collaborators: Academisch Ziekenhuis Maastricht; Thorax Centrum Twente

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2014
• Primary Completion (Actual): March 8, 2018
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Duration; Pulmonary Vein Isolation; Cryoballoon therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NL47337.044.13