Paroxysmal Atrial Fibrillation
Conditions
Brief summary
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.
Interventions
DEVICEHD Mesh Ablation System
Ablation using the HD Mesh Ablation System
DRUGAnti-arrhythmic drugs
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug * Other inclusion criteria
Exclusion criteria
* Previous surgical or catheter ablation to treat AF * Permanent AF * Uncontrolled or unstable medical conditions * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Complications | 12 months | A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure. |
| Number of Participants With Serious Atrial Fibrillation Events | 12 months | Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead. |
| Number of Participants With Freedom From Symptomatic Atrial Fibrillation | 12 months | Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. | 12 months | Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory. |
| Number of Participants With Acute Procedural Success in Mesh Treated Patients. | During the mesh ablation procedure | Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter |
Countries
United States
Participant flow
Recruitment details
Between July 2008 and November 2009, 44 patients were enrolled into the study. The study Sponsor made a business decision in late November 2009 to terminate the trial early; enrollment was closed at that time.
Pre-assignment details
Of the 44 enrolled patients, a total of 36 patients were treated. Treated patients were followed for 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Mesh Ablation with HD Mesh Ablation System | 4 |
| Drug Treatment with anti-arrhythmic drugs | 3 |
| Roll-ins Investigator's first patients treated with mesh prior to the start of the study randomization. | 29 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Mesh | Drug | Roll-ins | Total |
|---|---|---|---|---|
| Age Continuous | 64.8 years STANDARD_DEVIATION 6.18 | 66.0 years STANDARD_DEVIATION 9.54 | 60.2 years STANDARD_DEVIATION 9.68 | 61.2 years STANDARD_DEVIATION 9.36 |
| Region of Enrollment United States | 4 participants | 3 participants | 29 participants | 36 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 20 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 4 | 2 / 3 | 23 / 29 |
| serious Total, serious adverse events | 2 / 4 | 0 / 3 | 16 / 29 |
Outcome results
Primary
Number of Participants With Freedom From Symptomatic Atrial Fibrillation
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
Time frame: 12 months
Population: All treated patients
Primary
Number of Participants With Major Complications
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Time frame: 12 months
Population: Patients who were treated with the HD Mesh Ablation System
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Number of Participants With Major Complications | 0 participants |
| Roll-ins | Number of Participants With Major Complications | 2 participants |
Primary
Number of Participants With Serious Atrial Fibrillation Events
Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.
Time frame: 12 months
Population: All treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Number of Participants With Serious Atrial Fibrillation Events | 1 participants |
| Roll-ins | Number of Participants With Serious Atrial Fibrillation Events | 0 participants |
| Roll-ins | Number of Participants With Serious Atrial Fibrillation Events | 2 participants |
Secondary
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter
Time frame: During the mesh ablation procedure
Population: All mesh treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Number of Participants With Acute Procedural Success in Mesh Treated Patients. | 4 participants |
| Roll-ins | Number of Participants With Acute Procedural Success in Mesh Treated Patients. | 23 participants |
Secondary
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.
Time frame: 12 months
Population: All mesh treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh | Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. | 0 participants |
| Roll-ins | Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. | 0 participants |