Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SD-CRYO-AF  

Official title:

Efficacy of Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-Cryo-AF): A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003975
• Other study ID #: SD-CRYO-AF
• Status: Completed
• Phase: N/A
• First received: December 9, 2016
• Last updated: May 7, 2017
• Start date: November 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).

Description:

This is a prospective, randomized clinical study performed at one centre. The objective is to assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation in patients with atrial fibrillation (AF).

140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF ablation procedures will be enrolled.

Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala University Hospital, Uppsala, Sweden.

Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.

Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Patients will be randomized to a single cryoballoon application guided by a multipolar recording catheter or to a conventional technique with 2 cryoballoon applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a separate circular mapping catheter. Acute procedural success is defined as complete electrical isolation of a pulmonary vein assessed by entrance and exit block, including 20 minutes waiting time. Complications and duration of the procedure will be assessed.

Patients will be followed at three, six and 12 months after the ablation procedure. A 12 lead ECG, a 7 day Holter monitoring, quality of life (EQ5D) and EHRA score, will be performed at baseline, 6 and 12 months. as well as Biomarkers including nTproBNP and troponin I, will be performed at baseline, and at 6 and 12 months (only nTproBNP). Predictive variables for successful outcome/AF recurrence will be analysed.

The frequency of symptomatic recurrence of AF and number of reablations will be compared at 6 and 12 months, and in those requiring a redo ablation procedure the status of PV reconduction will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with paroxysmal or persistent AF verified by ECG

• Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.

Exclusion Criteria:

• Sinus rhythm cannot be maintained for at least one hour after an electrical cardioversion.

• Congestive heart failure with New York Heart Association (NYHA) class 3 or more.

• Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate control, according to the judgement of the investigator.

• Left atrial diameter = 55 mm judged by transthoracic echocardiography.

• Prior AF ablation procedure.

• Longstanding persistent AF

• AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.

• Contraindication to treatment with anticoagulants.

• Significant valvular disease or planned cardiac intervention.

• Hypertrophic cardiomyopathy.

• Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease

• Implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device.

• Dual chamber- and single chamber-pacemaker when the patient is pacemaker dependent on ventricular level

• Patients with contraindications for transseptal catheterization or appropriate vascular access is precluded.

• Renal failure requiring dialysis or abnormalities of liver function tests.

• Participant in investigational clinical or device trial.

• Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.

• Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• PVI by single cryoballoon application guided by Achieve Mapping Catheter
Pulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff < or = -40 degrees C)
• PVI by 2 routine cryoballoon applications
Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician

Locations

Country	Name	City	State
Sweden	Department of Cardiology, University Hospital in Uppsala	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of acute pulmonary vein isolation after first ablation.	Frequency of complete pulmonary vein isolation after first pass of ablation as per protocol	Acute during ablation procedure
Secondary	Procedure time	Procedure time of AF ablation (from initial puncture to removal of sheaths)	During ablation procedure
Secondary	Fluoroscopy exposure	Total time of fluoroscopy for AF ablation	During ablation procedure
Secondary	Freedom from atrial fibrillation	No atrial fibrillation after first ablation	Evaluated after 12 months
Secondary	Adverse/Serious Adverse events	Complications during and after ablation	Evaluated after 12 months
Secondary	Quality of Life after ablation	Quality of life assessed by EQ5D after ablation compared to baseline	Evaluated after 12 months
Secondary	Reduction of symptom severity score after ablation	Symptoms Severity Questionnaire, score reduction after ablation	Evaluated after 12 months
Secondary	Reduction of overall symptoms of atrial fibrillation after ablation	Symptom assessed by EHRA Symptom Classification score reduction after ablation	Evaluated after 12 months
Secondary	Cost of ablation procedure	Assessed by time for procedure, used resources and equipment during/after ablation	Evaluated after initial ablation (within 24 h after ablation)
Secondary	Quality of life after ablation (measured as EQ5D score)	EQ5D measured before ablation and after 12 months	Evaluated after 12 months
Secondary	Hospitalisation after ablation	hospitalisation (no of days)	Evaluated after 12 months
Secondary	Maximum troponin I (ng/L) levels after ablation as a predictor of clinical success	Maximum troponin I (ng/L) levels as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	Nt-proBNP levels before ablation as a predictor of clinical success	Nt-proBNP levels as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	Left atrial diameter (mm) before ablation as a predictor of clinical success	Left atrial diameter in mm (LAX view) as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	Left atrial volume (ml/m2) before ablation as a predictor of clinical success	Left atrial volume (ml/m2) as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	Age (years) as a predictor of clinical success	Age at ablation (years) as a predictor of freedom from AF after 12 months; 2 groups; < 70 and >70 years old	Evaluated after 12 months
Secondary	Sex as a predictor of clinical success	Sex as a predictor of freedom from AF after 12 months. 2 groups; male vs females	Evaluated after 12 months
Secondary	CHADsVASc score as a predictor of clinical success	CHADsVASc score as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	BMI (kg/m2) as a predictor of clinical success	BMI (kg/m2) as a predictor of freedom from AF after 12 months	Evaluated after 12 months
Secondary	Atrial conduction time as a predictor of clinical success	Mean conduction time over left atrium as a predictor of freedom from AF after 12 months	Evaluated after 12 months