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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| Abbott Medical Devices | INDUSTRY |
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The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacologic Therapy | Active Comparator | Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug. |
|
| Ablation Therapy | Active Comparator | Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rate Control | Drug | Metoprolol 50-100mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | Documentation of atrial fibrillation using a cardiac event recorder | 12 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas L. Packer, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtity of Alabama Hospital | Birminham | Alabama | 35233 | United States | ||
| Good Samaritan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20498271 | Background | Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Therapy | Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ablation Therapy | Device |
|
|
| Rate Control | Drug | Atenolol 50-100mg, |
|
|
| Rate control | Drug | Propranolol 40-80mg |
|
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| Rate control | Drug | Acebutolol 200mg |
|
|
| Rate control | Drug | Carvedilol 6.25mg |
|
|
| Rate Control | Drug | Diltiazem 180-240mg |
|
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| Rate Control | Drug | Verapamil 180-240mg |
|
|
| Rate Control | Drug | Digoxin 0.125mg |
|
|
| Rhythm Control | Drug | Propafenone 450mg |
|
|
| Rhythm control | Drug | Flecainide 200mg |
|
|
| Rhythm control | Drug | Sotalol 240mg |
|
|
| Rhythm control | Drug | Dofetilide 500mcg |
|
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| Rhythm control | Drug | Amiodarone 200mg |
|
|
| Rhythm control | Drug | Quinidine 600-900mg |
|
|
| Los Angeles |
| California |
| 90017 |
| United States |
| Loyola University | Maywood | Illinois | 60626 | United States |
| Mercy Medical Center | Des Moines | Iowa | 50314 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania Health | Philadelphia | Pennsylvania | 19104 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| FG001 | Ablation Therapy | Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug Therapy | Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg. |
| BG001 | Ablation Therapy | Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | Documentation of atrial fibrillation using a cardiac event recorder | Posted | Number | participants | 12 months after intervention |
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|
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Subjects were followed for adverse events for the 1 year they were on this trial.
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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 | Drug Therapy | Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg. | 4 | 31 | 8 | 31 | ||
| EG001 | Ablation Therapy | Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. | 12 | 29 | 10 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Adverse | General disorders | MedDRA | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arteriovenous Fistula | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular Injury | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Rash | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Transient Ischaemic Attack | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
Limited number enrolled. Study was designed to demonstrate feasibility for a pivotal trial, but small enrollment limits the final conclusions that can be drawn from a simple 'time to first atrial fibrillation recurrence.'
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristi Monahan | Mayo Clinic | 507-255-6676 | CABANA@mayo.edu |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| D008790 | Metoprolol |
| D001262 | Atenolol |
| D011433 | Propranolol |
| D000070 | Acebutolol |
| D000077261 | Carvedilol |
| D004110 | Diltiazem |
| D014700 | Verapamil |
| D004077 | Digoxin |
| D013015 | Sotalol |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001552 | Benzazepines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004983 | Ethanolamines |
| D001572 | Benzofurans |
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| >=65 years |
|
| Male |
|