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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.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Catheter Ablation Drug: Drug Treatment Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Progression Trial
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Catheter Ablation
Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)
Device: Catheter Ablation
Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
Other Name: CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter Family

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Rate and time to persistent AF/AT [ Time Frame: 1 year and 2 years ]
  2. Rate of persistent AF/AT by number of ablations [ Time Frame: 3 years ]
  3. Number of repeat ablations and new antiarrhythmic drugs [ Time Frame: 3 years ]
  4. Rhythm (% subjects in Sinus Rhythm, % subjects with recurrent atrial fibrillation) [ Time Frame: 3 years ]
  5. Subject's pre-existing or new onset/worsened condition(s), that may be associated with progression of atrial fibrillation [ Time Frame: 3 years ]
  6. Catheter-related complications (ablation); adverse drug reactions (AAD) [ Time Frame: Through 3 years follow-up ]
  7. Health care utilization (number and length of hospitalizations and unscheduled cardiovascular-related visits) [ Time Frame: Through 3 years follow-up ]
  8. Quality of Life [ Time Frame: At 3 months, 6 months, 1 year, 2 years and 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570361

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Sponsors and Collaborators
Biosense Webster, Inc.
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Principal Investigator: Karl-Heinz Kuck, MD Asklepios Klinik St. Georg

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Responsible Party: Biosense Webster, Inc. Identifier: NCT01570361    
Other Study ID Numbers: ATTEST
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes