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Persistent Atrial FibrillationABLATE-PASNCT01694563

ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation

A study testing Synergy Ablation System in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Synergy Ablation System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
49 sitesUnited States
Study dates
Sep 2012to 21 Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > or equal to 18 years of age
  • History of non-paroxysmal form of Atrial Fibrillation (AF) as defined by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society 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 Institutional Review Board (IRB) approved informed consent form.
  • Willing and able to return for scheduled follow up visits.

Who cannot join

  • 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 the results of this study.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Mission Hospital/Asheville Heart

    Asheville, North Carolina, 28803

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45242

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • UT Southwestern University Hospital

    Dallas, Texas, 75390

  • Northwestern Memorial Hospital

    Evanston, Illinois, 60208

  • Lee Memorial Hospital

    Fort Myers, Florida, 33901

  • University of Florida Cardiothoracic Surgery

    Gainesville, Florida, 32611

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Spectrum Health

    Grand Rapids, Michigan, 49506

  • Triad Cardiac and Thoracic Surgeons/Cone Health

    Greensboro, North Carolina, 27401

  • Pinnacle Health Hospitals

    Harrisburg, Pennsylvania, 17101

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • St. Francis Heart Hospital

    Indianapolis, Indiana, 46237

  • Inidiana Heart Center

    Indianapolis, Indiana, 46290

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48910

  • Nebraska Heart

    Lincoln, Nebraska, 68526

  • USC University Hospital

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • United Heart & Vascular/Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55102

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73135

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Hospital of the University of Pennsylvania (HUP)

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04102

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Scottsdale Healthcare Clinical Research Institute

    Scottsdale, Arizona, 85258

  • Swedish Medical Center

    Seattle, Washington, 98122

  • SIU- Memorial Medical Center

    Springfield, Illinois, 62794

  • Washington University

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Bayfront Medical Center

    St. Petersburg, Florida, 33701

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • James A. Haley Veteran's Hospital/Cardiothoracic Surgery

    Tampa, Florida, 33612

  • Pepin Heart Hospital

    Tampa, Florida, 33613

  • Toledo Hospital

    Toledo, Ohio, 43606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Cedars-Sinai Medical Center

    West Hollywood, California, 90048

  • Veteran Affairs Boston Healthcare System

    West Roxbury, Massachusetts, 02132

Other trials in United States

About this study

Official title: AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

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.

Read the 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.

Being tested
Synergy Ablation System
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synergy Ablation SystemDevice

    Also called Isolator Synergy Handpieces, Isolator Synergy Clamp

    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.
Study groups in NCT01694563
Study groupRoleWhat they receive
Atrial FibrillationOtherPatients 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.
Receives: Device: Synergy Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.

    The number of participants 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 as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.

    Measured: 36 months post-operatively

Secondary outcomes (1)

  1. Secondary Efficacy Outcome

    The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting > 30 continuous seconds duration of either Atrial Fibrillation, 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.

    Measured: 12, 24, and 36 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completion23 Oct 2017
  4. Study completion21 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01694563
Sponsor's protocol ID
CP2011-1
Acronym
ABLATE-PAS
Status last verified
Mar 2018
First submitted
24 Sep 2012
Last updated
9 Oct 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Synergy Ablation System in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks. (time frame: 36 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01694563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.

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