Longstanding Persistent Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief 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.
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.
Interventions
DEVICESynergy 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.
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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 the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 36 months post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Outcome | 12, 24, and 36 months post-operatively | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from: September 2012 thru October 2017
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 365 |
| Total | 365 |
Baseline characteristics
| Characteristic | Atrial Fibrillation |
|---|---|
| Age, Continuous | 69.8 years |
| History of Arrhythmia | 365 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 331 Participants |
| Region of Enrollment United States | 365 participants |
| Sex: Female, Male Female | 148 Participants |
| Sex: Female, Male Male | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 365 |
| other Total, other adverse events | 271 / 365 |
| serious Total, serious adverse events | 289 / 365 |
Outcome results
Primary
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.
Time frame: 36 months post-operatively
Population: Freedom from AF and off antiarrhythmic drugs (AADs) at specific time points. The participants that met the endpoint are reflected in the Outcome Measure Data Table.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 36 Months Post-operatively | 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. | 146 Participants |
Comparison: The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.p-value: 0.05Fisher Exact
Secondary
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.
Time frame: 12, 24, and 36 months post-operatively
Population: Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage. The participants that met the endpoint are reflected in the Outcome Measure Data Table.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 36 Months Post-operatively | Secondary Efficacy Outcome | 216 Participants |
| 24 Months Post-operatively | Secondary Efficacy Outcome | 187 Participants |
| 36 Months Post-operatively | Secondary Efficacy Outcome | 168 Participants |
Comparison: Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.
Comparison: Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.
Comparison: Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.