Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation

NCT02294929 | Unknown

• 1 other identifier: CRYO-LPAF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

catheter ablation; cryoballoon

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Clinical success defined as: * Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter provided AF is absent or paroxysmal in nature AF, or * Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.

  12 months

Secondary Outcomes (12)

• Complete freedom from AF

  6, 12 months

• Rhythm assessed by % of subjects in sinus rhythm, paroxysmal AF and persistent AF

  12 months

• Atrial Fibrillation burden

  12 months

• Role of Pulmonary vein isolation for elimination of atrial fibrillation

  12 months

• Quality of life

  12 months

Other Outcomes (1)

• Is sinus rhythm obtained by AF ablation superior to AF with regard to all secondary endpoints ?

  12 months

Study Arms (1)

Atrial fibrillation ablation

OTHER

Cryoballoon ablation for pulmonary vein isolation

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

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

Also known as: Medtronic Arctic Front™ Advance Cardiac CryoAblation System, The Arctic Front™ Advance Cardiac CryoAblation Catheter, The FlexCath™ Steerable Sheath, CryoCath Cryoablation Console

Atrial fibrillation ablation

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrial fibrillation should be confirmed on at least 2 consecutive ECG supporting the presence of AF for at least one year.
• Patients with symptoms corresponding to at least EHRA score 2.
• Patients, who have not previously undergone an AF ablation procedure, should have failed at least a betablocker or class I or III antiarrhythmic drug.

You may not qualify if:

• Sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
• Congestive heart failure with NYHA class 3 or more.
• LVEF \< 35% which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.
• LA diameter ≥ 55 mm by echocardiography.
• Prior AF ablation procedure of any kind.
• 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 Warfarin or other 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), biventricular pacing device, or Dual chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
• Patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality in whom 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Swedish Heart Lung Foundation: collaborator
• Medtronic: collaborator

Study Sites (1)

Carina Blomström Lundqvist

Uppsala, 75185, Sweden

RECRUITING

Related Publications (1)

• Aytemir K, Gurses KM, Yalcin MU, Kocyigit D, Dural M, Evranos B, Yorgun H, Ates AH, Sahiner ML, Kaya EB, Oto MA. Safety and efficacy outcomes in patients undergoing pulmonary vein isolation with second-generation cryoballoondagger. Europace. 2015 Mar;17(3):379-87. doi: 10.1093/europace/euu273. Epub 2014 Nov 5.

  PMID: 25376699 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carina M Blomström Lundqvist, Professor

  Department of Cardiology, Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina M Blomström Lundqvist, Professor

CONTACT

+46186113113; carina.blomstrom.lundqvist@akademiska.se

Eva-Maria Hedin, Study nurse

CONTACT

+46186112735; eva-maria.hedin@medsci.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 19, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

SE (1)