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To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Front Advance Cardiac CryoAblation Catheter | Device | Cryoablation |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. | Treatment failure is defined as any of the following components:
Blanking period is defined as the first 90 days after the index ablation procedure. Acute procedural failure is defined as:
| 12 Months |
| Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. | A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) | Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF). | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Calkins, MD | Johns Hopkins University | Principal Investigator |
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner-University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Colorado Heart and Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32590151 | Derived | Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Intent to Treat (mITT) Group | Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter |
| FG001 | Not Treated | Subjects enrolled, but not treated with an Arctic Front Advance Cryoablation catheter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 4 | Nov 10, 2016 | Aug 11, 2020 |
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Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
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| Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component | Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). | Baseline and 12 months |
| Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component | Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). | Baseline and 12 months |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Cardiac Arrhythmia Service | Boca Raton | Florida | 33432 | United States |
| Saint Vincent's Medical Center | Jacksonville | Florida | 32204 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201-1718 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287-0005 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| St. Luke's Health System | Kansas City | Missouri | 64111 | United States |
| Englewood Hospital & Medical Center | Englewood | New Jersey | 07631-1808 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Northwell Health (Lenox Hill Hospital and Staten Island University Hospital) | New York | New York | 10075-1851 | United States |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | United States |
| Doylestown Health Cardiology | Doylestown | Pennsylvania | 18901 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8802 | United States |
| Baylor Research Institute | Dallas | Texas | 75226 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Victoria Cardiac Arrhythmia Trials | Victoria | British Columbia | V8T 1Z4 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | G1V 4G5 | Canada |
| Tokyo Medical and Dental University | Bunkyō | Tokyo | 113-8519 | Japan |
| Jikei University Hospital | Tokyo | Japan |
| Yokohama City Minato Red Cross Hospital | Yokohama | 231-8682 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population includes those subjects who were enrolled and underwent ablation with an Arctic Front Advance CryoAblation catheter.
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Intent to Treat Group (mITT) | Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter |
| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Time from Persistent Atrial Fibrillation (AF) Onset | Mean | Standard Deviation | years |
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| Duration of Longest Persistent AF Episode | Median | Full Range | days |
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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 | Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. | Treatment failure is defined as any of the following components:
Blanking period is defined as the first 90 days after the index ablation procedure. Acute procedural failure is defined as:
| Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months |
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| Primary | Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. | A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:
| Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
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| Secondary | Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) | Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF). | Treated subjects completing at least 50% of questions on AFEQT questionnaires at both baseline and 12-month visits | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 months |
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| Secondary | Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component | Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). | Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 months |
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| Secondary | Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component | Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). | Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 months |
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All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation 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 | Enrolled Subjects | All enrolled and consented subjects | 0 | 186 | 34 | 186 | 52 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Aortic perforation | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Labyrinthitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
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| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
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| Puncture site haematoma | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
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| Ureteric injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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Principle Investigator (PI) agrees they will not independently discuss or publish trial results until a multi-center publication is released. If a multi-center publication is not released within one year after completion of the Study at all Study sites, PIs will have the right to publish the results of and information pertaining to their activities. Any such Publication must be submitted to Medtronic for review and comment at least sixty (60) days prior to submission or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Sauline, Clinical Research Specialist | Medtronic | 440-596-3529 | mary.k.sauline@medtronic.com |
| Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Version 5 | Apr 17, 2017 | Aug 11, 2020 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Version 6 | Dec 1, 2017 | Aug 11, 2020 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2019 | Aug 11, 2020 | SAP_000.pdf |
| 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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| Black |
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| Filipino |
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| Other Asian |
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| Subject/physician chose not to provide |
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| Japan |
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