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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01803438




Registration number
NCT01803438
Ethics application status
Date submitted
1/03/2013
Date registered
4/03/2013
Date last updated
25/02/2020

Titles & IDs
Public title
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
Scientific title
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.
Secondary ID [1] 0 0
Cryo-FIRST
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Antiarrhythmic Drugs

Active comparator: AADs - AAD therapy based on hospital clinical practice according to ESC Guidelines 2012

Experimental: Cryoablation procedure - electrical pulmonary veins isolation performed with cryoballoon ablation system


Treatment: Drugs: Antiarrhythmic Drugs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from any atrial arrhythmia recurrence
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
quality of life
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Hospital or emergency services accesses
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
Freedom from occurrence of AF
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Freedom from occurrence of documented left atrial tachycardia and left atrial flutter
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Symptomatic palpitations burden
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Severe adverse events incidence
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Freedom from persistent AF
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Echocardiographic left atrial re-modelling
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
health care utilization
Timepoint [9] 0 0
12 months

Eligibility
Key inclusion criteria
* Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above and at least two symptomatic episodes in the last six months prior to inclusion.
* At least one episode of AF must be documented during the prior year by any kind of ECG recording.
* Subject has structural normal heart with an LVEF = 50%, thickness of the inter-ventricular septum =12 mm and left atrium diameters (short axis) < 46 mm obtained by transthoracic echocardiography.
* Subject has normal ECG parameters (QRS width in the 12 channel surface ECG =120 ms, QTc - interval < 440 ms, PQ - interval = 210 ms; all parameters should be measured at sinus rhythm).
* Subject is at least 18 and not older than 75years old.
* Subject is able and willing to give informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration >7 days).

* Subject has documented typical atrial flutter.
* Subject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.
* Subject had any previous left atrial ablation.
* Subject had any previous cardiac surgery, e.g. prosthetic valves.
* Subject has permanent pacemaker or defibrillator implant.
* Subject has 2° type II, 3° degree AV-block or left/right bundle branch block pattern.
* Subject has unstable angina pectoris.
* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
* Subject has symptomatic carotid stenosis.
* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
* Subject has any contraindication for oral anticoagulation.
* Subject has any history of previous transient ischemic attack or stroke.
* Subject has known intra-cardiac thrombus formation.
* Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).
* Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.
* Subject has hypertrophic cardiomyopathy.
* Subject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.
* Subject has sarcoidosis.
* Subject has pulmonary vein stent.
* Subject has myxoma. Exclusion criteria based on laboratory abnormalities
* Subject has thrombocytosis (platelet count > 600,000 / µl) or thrombocytopenia (platelet count <100,000 / µl).
* Subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.
* Subject has renal dysfunction with glomerular filtration rate < 60 ml / min.
* Subject has known cryoglobulinaemia. General exclusion criteria
* Subject has a reversible causes for AF like hyperthyroidism and alcoholism.
* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] (who must have a negative pregnancy test within 1 week of the start of the therapy) or sterile woman can be enrolled.
* Subject is a breastfeeding woman.
* Subject has an active systemic infection.
* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
* Subject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer, severe bleeding in history or a suspected pro-coagulant state.
* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
* Subject has a life expectancy of = 1 year.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2020
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussel
Country [3] 0 0
Croatia
State/province [3] 0 0
Zagreb
Country [4] 0 0
France
State/province [4] 0 0
Amiens
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Rouen
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Nauheim
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Kaiserslautern
Country [12] 0 0
Germany
State/province [12] 0 0
Munich
Country [13] 0 0
Italy
State/province [13] 0 0
Cotignola
Country [14] 0 0
Italy
State/province [14] 0 0
Massa
Country [15] 0 0
Netherlands
State/province [15] 0 0
Eindhoven
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Norway
State/province [17] 0 0
Bergen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic Atrial Fibrillation Solutions
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Malte Kuniss, MD
Address 0 0
Kerckhoff - Klinik, Bad Nauheim, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01803438