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| ID | Type | Description | Link |
|---|---|---|---|
| IDE # G070179 |
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Business reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesh | Experimental | Ablation with HD Mesh Ablation System |
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| Drug | Active Comparator | Treatment with anti-arrhythmic drugs |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD Mesh Ablation System | Device | Ablation using the HD Mesh Ablation System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Number of Participants With Acute Procedural Success in Mesh Treated Patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Marie Harcarik | C. R. Bard, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Medical Center | San Diego | California | 92103 | United States | ||
| Aurora Denver Cardiology Associates |
Of the 44 enrolled patients, a total of 36 patients were treated. Treated patients were followed for 12 months.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mesh | Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur. |
| FG001 | Drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Anti-arrhythmic drugs |
| Drug |
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation |
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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 |
| During the mesh ablation procedure |
| Aurora |
| Colorado |
| 80012 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Florida Heart Group | Orlando | Florida | 32803 | United States |
| Bay Heart Group | Tampa | Florida | 33607 | United States |
| Piedmont Hospital Research Institute | Atlanta | Georgia | 30309 | United States |
| Northeast Cardiology Associates | Bangor | Maine | 04401 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| St. John's Medical Research Institute | Springfield | Missouri | 65807 | United States |
| Lehigh Valley Heart Specialists | Allentown | Pennsylvania | 18103 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
| FG002 | Roll-ins | Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mesh | Ablation with HD Mesh Ablation System |
| BG001 | Drug | Treatment with anti-arrhythmic drugs |
| BG002 | Roll-ins | Investigator's first patients treated with mesh prior to the start of the study randomization. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who were treated with the HD Mesh Ablation System | Posted | Number | participants | 12 months |
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| 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. | All treated patients. | Posted | Number | participants | 12 months |
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| 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. | All treated patients | Posted | 12 months |
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| 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. | All mesh treated patients. | Posted | Number | participants | 12 months |
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| 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 | All mesh treated patients. | Posted | Number | participants | During the mesh ablation procedure |
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12 months post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesh | Ablation with HD Mesh Ablation System | 2 | 4 | 3 | 4 | ||
| EG001 | Drug | Treatment with anti-arrhythmic drugs | 0 | 3 | 2 | 3 | ||
| EG002 | Roll-ins | Investigator's first patients treated with mesh prior to the start of the study randomization. | 16 | 29 | 23 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prothrombin time shortened | Investigations |
| |||
| Urinary tract infection | Infections and infestations |
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| Atrial fibrillation | Cardiac disorders | Note: not all 7 serious adverse events of atrial fibrillation met the predefined protocol criteria for the outcome measure of "Serious Atrial Fibrillation Events." |
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| Atrial flutter | Cardiac disorders |
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| Atrial tachycardia | Cardiac disorders |
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| Electrocardiogram ST segment elevation | Investigations |
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| Heart rate increased | Investigations |
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| Lactic acidosis | Metabolism and nutrition disorders |
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| Myoglobinuria | Renal and urinary disorders |
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| Esophageal fistula | Gastrointestinal disorders | Event was considered a protocol defined Major Complication; event resulted in patient death. |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders |
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| Pericardial effusion | Cardiac disorders | Event was considered a protocol defined Major Complication. A procedure was performed to remove the fluid and the event resolved. |
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| Sick sinus syndrome | Cardiac disorders |
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| Sinus arrhythmia | Cardiac disorders |
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| Subarachnoid hemorrhage | Nervous system disorders |
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| Synovial rupture | Injury, poisoning and procedural complications |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Atrial fibrillation | Cardiac disorders |
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| Atrial flutter | Cardiac disorders |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Carpal tunnel syndrome | Nervous system disorders |
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| Constipation | Gastrointestinal disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Depression | Psychiatric disorders |
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| Dizziness | Nervous system disorders |
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| Dysgeusia | Nervous system disorders |
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| Fatigue | General disorders |
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| Flank pain | Musculoskeletal and connective tissue disorders |
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| Flushing | Vascular disorders |
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| Groin pain | Musculoskeletal and connective tissue disorders |
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| Hematoma | Vascular disorders |
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| Hematuria | Renal and urinary disorders |
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| Hypertension | Vascular disorders |
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| Hypotension | Vascular disorders |
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| Nausea | Gastrointestinal disorders |
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| Non-cardiac chest pain | General disorders |
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| Edema peripheral | General disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Upper respiratory tract infection | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
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| Ventricular tachycardia | Cardiac disorders |
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| Contusion | Injury, poisoning and procedural complications |
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Due to the study's early termination and enrollment of only 7 randomized patients, predefined study endpoints were not evaluable. Treated patients were followed through 12 months postprocedure and data were summarized where possible.
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release at least 60 days prior to publication and that the multi-center results should be published prior to any individual site results unless the multi-center results are not published 2 years after the trial is complete. The only embargo that the sponsor can impose is on the release of confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Marie Harcarik | CR Bard | 908-277-8051 | annemarie.harcarik@crbard.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Male |
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