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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01570361




Registration number
NCT01570361
Ethics application status
Date submitted
28/03/2012
Date registered
4/04/2012
Date last updated
14/05/2020

Titles & IDs
Public title
Atrial Fibrillation Progression Trial
Scientific title
Atrial Fibrillation Progression Trial
Secondary ID [1] 0 0
ATTEST
Universal Trial Number (UTN)
Trial acronym
ATTEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Catheter Ablation
Treatment: Drugs - Drug Treatment

Experimental: Catheter Ablation - Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)

Active comparator: Drug Treatment - Drug therapy (either rate or rhythm control) using current AF management guidelines


Treatment: Devices: Catheter Ablation
Treat subjects with Paroxysmal Atrial Fibrillation (PAF)

Treatment: Drugs: Drug Treatment
Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Timepoint [4] 0 0
2 Years
Secondary outcome [5] 0 0
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Timepoint [5] 0 0
3 year
Secondary outcome [6] 0 0
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Number of Repeat Ablations
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Number of New Antiarrhythmic Drugs
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Timepoint [9] 0 0
3 months, 6 months, 1 year, 2 years, 3 years
Secondary outcome [10] 0 0
Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Timepoint [10] 0 0
3 months, 6 months, 1 year, 2 year and 3 years

Eligibility
Key inclusion criteria
1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with = 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
2. HATCH Score of at least =1 and =4.
3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
4. Age 60 years or older.
5. Left atrium (LA) diameter = 55mm by TTE.
6. Left ventricle (LV) ejection fraction =50% when in sinus rhythm or LV ejection fraction =35% when in atrial fibrillation.

NOTE: For patients entering the study in AF with an ejection fraction =35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study.
7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients awaiting cardiac transplantation or other cardiac surgery.
2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
5. Heart failure decompensation.
6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.
7. Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial flutter.
8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.
9. Pulmonary embolism or recent atrial embolism/thrombosis.
10. Hypertrophic obstructive cardiomyopathy.
11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).
12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.
13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.
15. Prior AV nodal ablation.
16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
18. Medical conditions limiting expected survival to <3 years.
19. Concurrent participation in any other clinical study.
20. Prior history of non-adherence to prescribed drug regimens.
21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.

NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2018
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Nauheim
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Göttingen
Country [8] 0 0
Germany
State/province [8] 0 0
Hamburg
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Italy
State/province [11] 0 0
Bari
Country [12] 0 0
Italy
State/province [12] 0 0
Pisa
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Latvia
State/province [15] 0 0
Riga
Country [16] 0 0
Norway
State/province [16] 0 0
Bergen
Country [17] 0 0
Poland
State/province [17] 0 0
Warszaw
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Krasnoyarsk
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Novosibirsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Saint-Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Tomsk
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Malaga
Country [25] 0 0
Spain
State/province [25] 0 0
Salamanca
Country [26] 0 0
Sweden
State/province [26] 0 0
Örebro
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Bournemouth
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Cambridge
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
Trial website
https://clinicaltrials.gov/study/NCT01570361
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karl-Heinz Kuck, MD
Address 0 0
Asklepios Klinik St. Georg
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01570361