Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation

Summary

Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.

44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF duration longer than one year, who have not previously undergone an AF ablation procedure, and have symptoms related to AF corresponding to at least European Heart Rhythm Association (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or class I or III antiarrhythmic drug.

Excluded are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction \< 40%, left atrial diameter ≥ 60 mm, significant valvular disease or planned cardiac intervention within next 12 months, and conventional contraindications for AF ablation procedures.

Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm. Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping catheter.

All patients will be subject to electroanatomical voltage mapping during sinus rhythm for demonstration of extent of atrial myocardial lesions after ablation.

Patients will be followed every third month up to one year after the ablation procedure. Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9 and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.

Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of freedom from AF, complications, hospitalization and Health economics.

Conditions

• Atrial Fibrillation

Interventions

PROCEDURE

Atrial fibrillation ablation

Atrial fibrillation ablation using the Arctic Front™ Advance Cardiac CryoAblation Catheter in two balloon sizes (23mm and 28mm) for pulmonary vein isolation

Sponsors & Collaborators

• Swedish Heart Lung Foundation

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Uppsala University Hospital

  lead OTHER

Principal Investigators

• Carina M Blomström Lundqvist, Professor · Department of Cardiology, Uppsala University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2018-09-30

Completion

2018-12-31

Countries

• Sweden

Study Locations