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
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cryoballoon ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Pulmonary Vein Isolation, Atrial fibrillation, Cryoballoon therapy, Duration
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.
Sites / Locations
- Medisch Spectrum Twente
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
2 times 1
2 times 2
2 times 3
Arm Description
PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute
PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes
PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Procedure time, fluoroscopy time, amount of contrast used
The assessment of this outcome will take place right after the procedure. It measures procedural parameters.
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.
Atrial Fibrillation recurrence
Balloon temperatures measured by the console
Full Information
NCT ID
NCT02074566
First Posted
February 10, 2014
Last Updated
March 10, 2020
Sponsor
Harald Verheij
Collaborators
Thorax Centrum Twente, Academisch Ziekenhuis Maastricht
1. Study Identification
Unique Protocol Identification Number
NCT02074566
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2014 (Actual)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Harald Verheij
Collaborators
Thorax Centrum Twente, Academisch Ziekenhuis Maastricht
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Pulmonary Vein Isolation, Atrial fibrillation, Cryoballoon therapy, Duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 times 1
Arm Type
Other
Arm Description
PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute
Arm Title
2 times 2
Arm Type
Other
Arm Description
PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes
Arm Title
2 times 3
Arm Type
Other
Arm Description
PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes
Intervention Type
Other
Intervention Name(s)
Cryoballoon ablation
Intervention Description
PVI using cryoballoon
Primary Outcome Measure Information:
Title
Number of patients wit successfull pulmonary vein isolation
Description
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.
Time Frame
up to 6 minutes
Secondary Outcome Measure Information:
Title
Number of complications
Description
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.
Time Frame
1 year
Title
Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present
Description
The assessment of this outcome will take place during the procedure
Time Frame
up to 6 minutes
Title
Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation
Description
The assessment of this outcome will take place during the procedure.
Time Frame
up to 6 minutes
Title
Procedure time, fluoroscopy time, amount of contrast used
Description
The assessment of this outcome will take place right after the procedure. It measures procedural parameters.
Time Frame
up to 6 minutes
Title
Lower Esophageal Temperature development
Description
The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.
Time Frame
up to 6 minutes
Title
Atrial Fibrillation recurrence
Time Frame
after 1 year follow up
Title
Balloon temperatures measured by the console
Time Frame
up to 6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Nederland
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
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
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