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Atrial Fibrillation Progression Trial (ATTEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01570361
First received: March 28, 2012
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine whether early radiofrequency ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with Paroxysmal AF (PAF), delays progression of atrial fibrillation compared with drug therapy (either rate or rhythm control) using current atrial fibrillation management guidelines.


Condition Intervention Phase
Atrial Fibrillation
Device: Left Atrial Ablation (Carto® 3, Carto® XP System, or Carto® RMT and ThermoCool®)
Drug: Rate or Rhythm Control Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Progression Trial

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Time to persistent atrial fibrillation/atrial tachycardia excluding isthmus-dependent atrial flutter [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
    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:
  • Rate and time to persistent AF/AT [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Rate of persistent AF/AT by number of ablations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of repeat ablations and new antiarrhythmic drugs [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rhythm (% subjects in Sinus Rhythm, % subjects with recurrent atrial fibrillation) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Subject's pre-existing or new onset/worsened condition(s), that may be associated with progression of atrial fibrillation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Catheter-related complications (ablation); adverse drug reactions (AAD) [ Time Frame: Through 3 years follow-up ] [ Designated as safety issue: Yes ]
  • Health care utilization (number and length of hospitalizations and unscheduled cardiovascular-related visits) [ Time Frame: Through 3 years follow-up ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At 3 months, 6 months, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: February 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter Ablation
Radiofrequency ablation treatment
Device: Left Atrial Ablation (Carto® 3, Carto® XP System, or Carto® RMT and ThermoCool®)
Catheter ablation with Carto® 3, Carto® XP System, or Carto® RMT System and ThermoCool® Catheter Family (NAVISTAR® THERMOCOOL® Catheter, EZ STEER® THERMOCOOL® NAV, THERMOCOOL® SF NAV, THERMOCOOL® SMARTTOUCH™ BI-DIRECTIONAL NAVIGATION, THERMOCOOL® SMARTTOUCH™ UNI-DIRECTIONAL NAVIGATION CATHETER)
Active Comparator: Drug Treatment Drug: Rate or Rhythm Control Therapy
Antiarrhythmic drugs (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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570361

Contacts
Contact: Jean-Marie Neyens jneyens1@its.jnj.com

  Show 38 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Karl-Heinz Kuck, MD Asklepios Klinik St. Georg
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01570361     History of Changes
Other Study ID Numbers: ATTEST
Study First Received: March 28, 2012
Last Updated: October 24, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014