COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Atrial Fibrillation Progression Trial (ATTEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570361
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : May 21, 2019
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE April 4, 2012
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE February 1, 2012
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
Time to persistent atrial fibrillation/atrial tachycardia excluding isthmus-dependent atrial flutter [ Time Frame: 3 year follow-up ]
Persistent atrial fibrillation/atrial tachycardia is defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Rate and time to persistent AF/AT [ Time Frame: 1 year and 2 years ]
  • Rate of persistent AF/AT by number of ablations [ Time Frame: 3 years ]
  • Number of repeat ablations and new antiarrhythmic drugs [ Time Frame: 3 years ]
  • Rhythm (% subjects in Sinus Rhythm, % subjects with recurrent atrial fibrillation) [ Time Frame: 3 years ]
  • Subject's pre-existing or new onset/worsened condition(s), that may be associated with progression of atrial fibrillation [ Time Frame: 3 years ]
  • Catheter-related complications (ablation); adverse drug reactions (AAD) [ Time Frame: Through 3 years follow-up ]
  • Health care utilization (number and length of hospitalizations and unscheduled cardiovascular-related visits) [ Time Frame: Through 3 years follow-up ]
  • Quality of Life [ Time Frame: At 3 months, 6 months, 1 year, 2 years and 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Atrial Fibrillation Progression Trial
Official Title  ICMJE Atrial Fibrillation Progression Trial
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.
Detailed Description Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Device: Catheter Ablation
    Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
    Other Name: CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter Family
  • Drug: 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.
    Other Name: Antiarrhythmic Drugs
Study Arms  ICMJE
  • Experimental: Catheter Ablation
    Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)
    Intervention: Device: Catheter Ablation
  • Active Comparator: Drug Treatment
    Drug therapy (either rate or rhythm control) using current AF management guidelines
    Intervention: Drug: Drug Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2012)
Actual Study Completion Date  ICMJE December 19, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Latvia,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
Removed Location Countries Czech Republic
Administrative Information
NCT Number  ICMJE NCT01570361
Other Study ID Numbers  ICMJE ATTEST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karl-Heinz Kuck, MD Asklepios Klinik St. Georg
PRS Account Biosense Webster, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP