Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02294929 |
Date of registration:
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12/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation
CRYO-LPAF |
Scientific title:
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Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Longstanding Persistent Atrial Fibrillation (the CRYO-LPAF Study) |
Date of first enrolment:
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September 2013 |
Target sample size:
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40 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02294929 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Carina M Blomström Lundqvist, Professor |
Address:
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Telephone:
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+46186113113 |
Email:
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carina.blomstrom.lundqvist@akademiska.se |
Affiliation:
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Name:
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Carina M Blomström Lundqvist, Professor |
Address:
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Telephone:
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+46186113113 |
Email:
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carina.blomstrom.lundqvist@akademiska.se |
Affiliation:
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Name:
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Carina M Blomström Lundqvist, Professor |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiology, Uppsala University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Atrial fibrillation should be confirmed on at least 2 consecutive ECG supporting the
presence of AF for at least one year.
3. Patients with symptoms corresponding to at least EHRA score 2.
4. 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 Criteria:
1. Sinus rhythm cannot be maintained for at least 1 minute after an electrical
cardioversion.
2. Congestive heart failure with NYHA class 3 or more.
3. LVEF < 35% which is not secondary to AF with inadequate rate control, according to the
judgement of the investigator.
4. LA diameter = 55 mm by echocardiography.
5. Prior AF ablation procedure of any kind.
6. 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.
7. Contraindication to treatment with Warfarin or other anticoagulants.
8. Significant valvular disease or planned cardiac intervention.
9. Hypertrophic cardiomyopathy.
10. Recent cardiac disease states within the last 6 months; unstable angina, acute
myocardial infarction, revascularisation procedures, valve disease
11. Implantable cardioverter-defibrillator (ICD), biventricular pacing device, or Dual
chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
12. Patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality
in whom transseptal catheterization or appropriate vascular access is precluded.
13. Renal failure requiring dialysis or abnormalities of liver function tests.
14. Participant in investigational clinical or device trial.
15. Unwilling or unable to give informed consent or inaccessible for follow-up and
psychological problem that might limit compliance.
16. Active abuse of alcohol or other substance which may be causative of AF and/or might
affect compliance.
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Procedure: Atrial fibrillation ablation
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Primary Outcome(s)
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Clinical success
[Time Frame: 12 months]
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Secondary Outcome(s)
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Role of Pulmonary vein isolation for elimination of atrial fibrillation
[Time Frame: 12 months]
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Prediction of freedom from AF
[Time Frame: 12 months]
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Left and right atrial size and function
[Time Frame: 12 months]
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Atrial Fibrillation burden
[Time Frame: 12 months]
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Quality of life
[Time Frame: 12 months]
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Scar tissue
[Time Frame: 12 months]
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Symptoms Severity Questionnaire and EHRA Symptom Classification
[Time Frame: 12 months]
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Catheter related complications
[Time Frame: 12 months]
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Rhythm assessed by % of subjects in sinus rhythm, paroxysmal AF and persistent AF
[Time Frame: 12 months]
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Biomarkers
[Time Frame: Baseline, 6 hours, 24 hours, 12 months]
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Complete freedom from AF
[Time Frame: 6, 12 months]
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Health economics
[Time Frame: 12 months]
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Secondary ID(s)
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CRYO-LPAF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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