Atrial Fibrillation
Conditions
Keywords
Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation
Brief summary
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
Detailed description
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Interventions
DEVICEAblation procedure staged catheter ablation
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 year * Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD). * Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure) * Life expectancy of at least two years * Patient will and able to provide informed consent * Patient is willing and able to attend the scheduled follow-up visits
Exclusion criteria
* Prior Cardiothoracic Surgery * Patient has NYHA (New York Heart Association) Class IV heart failure * Evidence of underlying structural heart disease requiring surgical treatment * Surgical procedure within the 30 days prior to the index procedure * Ejection fraction \< 30% * Measured left atrial diameter \> 6.0 cm * Renal Failure * Stroke within previous 6 months * Known carotid artery stenosis greater than 80% * Evidence of significant active infection or endocarditis * Pregnant woman or women desiring to become pregnant in the next 24 months * Presence of thrombus in the left atrium determined by echocardiography * History of blood dyscrasia * Contraindication to anticoagulation, based on Investigator's opinion * Mural thrombus or tumor * Moderate to Severe COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. | 30 days post-index procedure or hospital discharge | Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms. |
| Number of Subjects With Absence of Atrial Fibrillation | 12 month follow-up | Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject Without Atrial Fibrillation | 6 and 12 month follow-up | AF free with or without the need of antiarrhythmic drugs |
| Number of Subjects With Reinterventions | 12 month follow-up | — |
| Number Subjects With Serious Device or Procedure Related Adverse Event Rate | 12 month follow-up | — |
| Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores | 12 month follow-up | Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline. 1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology. 2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology. 3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology . |
| Number of Subjects With Direct Current (DC) Cardioversion | 12 month follow-up | — |
| Number of Subjects With Acute Procedure Success | Day 0 | Defined as subject meeting all of the following criteria upon completion of the index-EP procedure 1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); 2. Bi-directional cavotricuspid isthmus block; 3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); 4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed. |
Countries
Belgium, Netherlands, United States
Participant flow
Recruitment details
First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.
Pre-assignment details
Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | AtriCure Bipolar System Combined With a Catheter Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.5 |
| Body Mass Index (BMI) | 30.8 kg/m2 STANDARD_DEVIATION 3.9 |
| Height | 71.0 inches STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
| Weight | 220.9 Lbs. STANDARD_DEVIATION 35.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 26 |
| serious Total, serious adverse events | 12 / 26 |
Outcome results
Primary
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Time frame: 30 days post-index procedure or hospital discharge
Population: Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. | 3 Participants |
Primary
Number of Subjects With Absence of Atrial Fibrillation
Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
Time frame: 12 month follow-up
Population: Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subjects With Absence of Atrial Fibrillation | 18 Participants |
Secondary
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline. 1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology. 2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology. 3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
Time frame: 12 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores | Checklist Frequency Score | -16.3 percentage of from baseline | Standard Deviation 8.6 |
| AtriCure Bipolar System Combined With a Catheter Ablation | Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores | Checklist Severity Score | -12.6 percentage of from baseline | Standard Deviation 7 |
Secondary
Number of Subjects With Acute Procedure Success
Defined as subject meeting all of the following criteria upon completion of the index-EP procedure 1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); 2. Bi-directional cavotricuspid isthmus block; 3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); 4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subjects With Acute Procedure Success | 19 Participants |
Secondary
Number of Subjects With Direct Current (DC) Cardioversion
Time frame: 12 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subjects With Direct Current (DC) Cardioversion | 6 Participants |
Secondary
Number of Subjects With Reinterventions
Time frame: 12 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subjects With Reinterventions | 8 Participants |
Secondary
Number of Subject Without Atrial Fibrillation
AF free with or without the need of antiarrhythmic drugs
Time frame: 6 and 12 month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subject Without Atrial Fibrillation | 6-Months Follow-Up | 17 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Subject Without Atrial Fibrillation | 12-Months Follow-Up | 19 Participants |
Secondary
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Time frame: 12 month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number Subjects With Serious Device or Procedure Related Adverse Event Rate | Epicardial AF Procedure | 6 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Number Subjects With Serious Device or Procedure Related Adverse Event Rate | Investigational Device | 0 Participants |