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ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal AF (ABLATE PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01694563
First received: September 24, 2012
Last updated: July 15, 2016
Last verified: July 2016
History of Changes
  Purpose
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.

Condition Intervention
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
 Device: Synergy Ablation System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Primary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operatively ] [ Designated as safety issue: No ]
    Proportion of patients free from atrial fibrillation (AF), i.e., episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks (except amiodarone which must be 12 weeks prior to the assessment) as determined by core last assessment of a 48 hour Holter, Zio Patch or PPM interrogation recording performed at a minimum of 12, 24 and 36 months postoperatively (hypothesis test at 36 months).


Secondary Outcome Measures:
  • Secondary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operative procedure ] [ Designated as safety issue: No ]
    Proportion of patients free from AF regardless of antiarrhythmic drug usage (i.e., no episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia) as determined by an independent core lab assessment of 48 hour Holter, Zio Patch or PPM interrogation recording performed at a minimum of 12, 24 and 36 months post-operatively.

  • Secondary Safety Outcomes [ Time Frame: Through 30 days post-operative or hospital discharge, whichever is later. ] [ Designated as safety issue: Yes ]

    Composite major adverse event: Serious adverse events occuring post-operatively within 30 days post-procedure or hospital discharge (whichever is later) including:

    • death (includes deaths after 30 days or hospital discharge if death is procedure related)
    • Stroke (resulting in significant permanent disability)
    • TIA
    • Myocardial infarction
    • Excessive bleeding (requiring >2 units of blood replacement and surgical intervention).


Other Outcome Measures:
  • Primary Safety Outcomes [ Time Frame: Through 30 days post-operatively or hospital discharge, whichever is later ] [ Designated as safety issue: Yes ]
    Proportion of patients with any serious device or ablation procedure-related adverse events within 30 days post procedure or hospital discharge (whichever is later) as adjudicated by a Clinical Events Committee (CEC).

  • Pacemaker implantation [ Time Frame: within 30 days post-procedure ] [ Designated as safety issue: Yes ]
    Pacemaker implantation within 30 days post-procedure will be summary and reported by reason for PPM.
Enrollment: 365
Study Start Date: September 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Atrial Fibrillation
Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use.
 Device: Synergy Ablation System

Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:

  • Coronary Artery Bypass Grafting (CABG)
  • Mitral valve repair or replacement
  • Aortic valve repair or replacement
  • Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.
Other Names:
  • Isolator Synergy Handpieces
  • Isolator Synergy Clamp

Detailed Description:
This prospective, open label, multi-center, observational, single arm registry is designed to monitor the AtriCure Synergy Ablation System continued safety and efficacy during the peri-procedural and long-term phase during commercial use in patients being treated for non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump cardiac surgical procedure.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a history of non-paroxysmal forms of atrial fibrillation (AF), persistent or longstanding persistent, who are undergoing an elective open cardiac surgical procedure.
Criteria

Inclusion Criteria:

  • Age > or equal to 18 years of age

  • History of non-paroxysmal form of AF as defined by the HRS/EHRA/ECAS Consensus Statement:

    • Persistent AF shall be defined as continuous AF that is sustained beyond seven days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after greater than or equal to 48 hours of AF but prior to 7 days, should also be classified as persistent AF episodes.
    • Longstanding persistent AF shall be defined as continuous AF of greater than 12 months duration. The performance of a successful cardioversion (sinus rhythm >30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF with 30 days should not alter the classification of AF as longstanding persistent.
  • Subject is scheduled to undergo elective open cardiac surgical procedure(s) to be performed on cardiopulmonary bypass for one or more of the following: Coronary Artery Bypass Grafting, Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement. In conjunction with these procedure patent foramen ovale (PFO) or atrial septal defect (ASD) repair are allowed.
  • The patient (or their legally authorized representative) agrees to participate in this study by singing the IRB approved informed consent form.
  • Willing and able to return for scheduled follow up visits.

Exclusion Criteria:

  • Stand along AF without indication(s) for concomitant cardiac surgery.
  • Need for emergent cardiac surgery (i.e., cardiogenic shock).
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
  • Pregnancy or desire to get pregnant for the duration of the study concomitant surgical procedure through the thirty six (36) month follow up period).
  • Enrolled in another clinical trial that could confound th e results of this study.
  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: NCT01694563

  Show 49 Study Locations
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Study Chair: Patrick McCarthy, MD Chief, Division of Cardiac Surgery, Northwestern University
  More Information

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01694563     History of Changes
Obsolete Identifiers: NCT01174745
Other Study ID Numbers: CP2011-1 
Study First Received: September 24, 2012
Last Updated: July 15, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on September 30, 2016