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

NCT ID: NCT03003975

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-03-31

Brief 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).

Detailed 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PVI by single cryoballoon application

A single cryoballoon application for pulmonary vein isolation will be guided by a Multipolar Recording Catheter (Achieve Mapping Catheter), passed through the inner lumen of the cryoablation catheter. A single application of 4 minutes will be used per vein guided by recording of loss of electrograms and by a defined drop of temperature within 2 minutes application. If a stable position with adequate occlusion of the vein the Achieve catheter should be located proximally for evaluation of entrance block during application, but can be advanced deeper for stability and then retracted to the ostium to evaluate vein isolation (entrance block).

If the vein then is isolated after a single application, the operator can move on to the next vein.

Group Type: ACTIVE_COMPARATOR

PVI by single cryoballoon application guided by Achieve Mapping Catheter

Intervention Type: DEVICE

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 cryo applications

Cryoballoon ablation with a conventional guidewire passed through the inner lumen of the catheter for stability will be used. Ablation will be performed with 2 consecutive applications for 4 minutes each in each vein guided by degree of occlusion and temperature drop at the discretion of the physician.

Group Type: ACTIVE_COMPARATOR

PVI by 2 routine cryoballoon applications

Intervention Type: DEVICE

Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician

Interventions

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)

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Other Intervention Names

Arctic Front™ Advance Cardiac CryoAblation Catheter; Achieve Mapping Catheter; Arctic Front™ Advance Cardiac CryoAblation Catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carina Blomstrom Lundqvist

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carina Blomström Lundqvist, Professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Department of Cardiology, University Hospital in Uppsala

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

SD-CRYO-AF

Identifier Type: -

Identifier Source: org_study_id