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unable to reach enrollment goal
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.
The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF catheter Ablation | Active Comparator | Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF |
|
| FDA approved anti arrhythmic drug | Active Comparator | FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Device | During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF. |
| Measure | Description | Time Frame |
|---|---|---|
| First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion | Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Cardiovascular Hospitalization | total number of cardiovascular hospitalization measured by hospitalization admissions | 15 months |
| Time to Recurrence if AF Lasting Longer Than 30 Seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oussama Wazni, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| Cleveland Clinic Akron General |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7062992 | Background | Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703. | |
| 9155607 | Background | Van den Berg MP, Tuinenburg AE, Crijns HJ, Van Gelder IC, Gosselink AT, Lie KI. Heart failure and atrial fibrillation: current concepts and controversies. Heart. 1997 Apr;77(4):309-13. doi: 10.1136/hrt.77.4.309. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AF Catheter Ablation | Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF. |
| FG001 | FDA Approved Anti Arrhythmic Drug | FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines. FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Trial terminated due to poor enrollment and no analysis was performed. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
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| ID | Title | Description |
|---|---|---|
| BG000 | AF Catheter Ablation | Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. |
| 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 | First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion | Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed). | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | 12 months |
|
Up to 12 months
Trial was terminated before the outcome measure data were collected.
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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 | AF Catheter Ablation | Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF. |
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Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oussama Wazni, MD | Cleveland Clinic | 216-444-2131 | waznio@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2017 | Jun 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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Study randomizes subjects to already FDA approved treatment modalities. Approved anti-arrhythmic medications or AF ablation. There are no investigational drug or devices used.
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|
|
| FDA approved anti arrhythmic drug | Drug | Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines |
|
time measured in days to recurrence of AF lasting longer than 30 seconds
| 15 months |
| Distance Walked in a 6-mile Walk Test | change in distance walked in 6 mile walk test | 3 months through 15 months |
| Change in the Rand 36-Item Health Survey | change in the Rand 36-Item Health Survey reflective of change in patient's quality of life | 3 months through 15 months |
| Change in Ejection Fraction (EF) | Change in Ejection Fraction heart failure measurement (percentage) | baseline through15 months |
| Akron |
| Ohio |
| 44307 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 15028358 | Background | Chen MS, Marrouche NF, Khaykin Y, Gillinov AM, Wazni O, Martin DO, Rossillo A, Verma A, Cummings J, Erciyes D, Saad E, Bhargava M, Bash D, Schweikert R, Burkhardt D, Williams-Andrews M, Perez-Lugones A, Abdul-Karim A, Saliba W, Natale A. Pulmonary vein isolation for the treatment of atrial fibrillation in patients with impaired systolic function. J Am Coll Cardiol. 2004 Mar 17;43(6):1004-9. doi: 10.1016/j.jacc.2003.09.056. |
| 14574035 | Background | Wyse DG. Some recent randomized clinical trials in the management of atrial fibrillation. J Interv Card Electrophysiol. 2003 Oct;9(2):223-8. doi: 10.1023/a:1026292609252. |
| 15007003 | Background | Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8. |
| BG001 | FDA Approved Anti Arrhythmic Drug | FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines. FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Number | participants |
|
| OG001 | FDA Approved Anti Arrhythmic Drug | FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines. FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines |
|
| Secondary | Total Number of Cardiovascular Hospitalization | total number of cardiovascular hospitalization measured by hospitalization admissions | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | 15 months |
|
|
| Secondary | Time to Recurrence if AF Lasting Longer Than 30 Seconds | time measured in days to recurrence of AF lasting longer than 30 seconds | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | 15 months |
|
|
| Secondary | Distance Walked in a 6-mile Walk Test | change in distance walked in 6 mile walk test | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | 3 months through 15 months |
|
|
| Secondary | Change in the Rand 36-Item Health Survey | change in the Rand 36-Item Health Survey reflective of change in patient's quality of life | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | 3 months through 15 months |
|
|
| Secondary | Change in Ejection Fraction (EF) | Change in Ejection Fraction heart failure measurement (percentage) | Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | baseline through15 months |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | FDA Approved Anti Arrhythmic Drug | FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines. FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines | 0 | 2 | 0 | 2 | 0 | 2 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |