Status:
UNKNOWN
Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation
Lead Sponsor:
Uppsala University Hospital
Collaborating Sponsors:
Swedish Heart Lung Foundation
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
30-70 years
Phase:
NA
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 persis...
Detailed Description
This is a prospective and explorative clinical study performed at one centre. Objective: The objective of this study is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Fro...
Eligibility Criteria
Inclusion
- Patients with longstanding persistent AF, with continuous AF of greater than one year, as verified by ECG or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
- 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.
Exclusion
- 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.
- Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02294929
Start Date
September 1 2013
End Date
December 1 2018
Last Update
May 9 2017
Active Locations (1)
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1
Carina Blomström Lundqvist
Uppsala, Sweden, 75185