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
- Conditions
- Atrial Fibrillation
- Interventions
- Other: Cryoballoon ablation
- Registration Number
- NCT02074566
- Lead Sponsor
- Harald Verheij
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 times 1 Cryoballoon ablation PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute 2 times 2 Cryoballoon ablation PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes 2 times 3 Cryoballoon ablation PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes
- Primary Outcome Measures
Name Time Method Number of patients wit successfull pulmonary vein isolation up to 6 minutes 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
Name Time Method Number of complications 1 year Complications being:
1. Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation.
2. Temperatures reaching \<12 C in the oesophagus during cryoablation.
3. 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 up to 6 minutes 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 up to 6 minutes The assessment of this outcome will take place during the procedure.
Lower Esophageal Temperature development up to 6 minutes The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.
Procedure time, fluoroscopy time, amount of contrast used up to 6 minutes The assessment of this outcome will take place right after the procedure. It measures procedural parameters.
Atrial Fibrillation recurrence after 1 year follow up Balloon temperatures measured by the console up to 6 minutes
Trial Locations
- Locations (2)
Medisch Spectrum Twente
🇳🇱Enschede, Nederland, Netherlands
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands