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Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS) (STOP AF PAS)
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01456949
First received: October 19, 2011
Last updated: August 28, 2017
Last verified: August 2017
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Purpose
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
| Condition | Intervention | Phase |
|---|---|---|
| Paroxysmal Atrial Fibrillation (PAF) | Device: Medtronic Arctic Front® Cardiac CryoAblation System | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS) |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Medtronic Atrial Fibrillation Solutions:
Primary Outcome Measures:
- Effectiveness [ Time Frame: Through 36 months ]
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
Chronic treatment failure is defined as:
- Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
- Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
- Safety [ Time Frame: 12 Months ]Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
Secondary Outcome Measures:
- Chronic Safety [ Time Frame: Annually, through 3 years ]Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.
- Chronic Effectiveness [ Time Frame: Annually, through 3 years ]
Freedom from chronic treatment failure, defined as:
- Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
- Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
| Enrollment: | 402 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Single Arm
Cryoablation
|
Device: Medtronic Arctic Front® Cardiac CryoAblation System
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Other Names:
|
Detailed Description:
Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDA. The criteria set in this study have been previously used to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation.
The analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. The analysis of the primary safety objective will take place once all the subjects with a study cryoablation procedure attempt have reached 12 months of follow-up post-cryoablation procedure. The analyses for the secondary objectives will take place once all subjects with a study cryoablation attempt have reached 36 months of follow-up post-cryoablation procedure.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Documented PAF:
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- 2 or more episodes of AF during the 3 months preceding the consent Date, AND
- At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
- Age 18 years or older
- Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
Exclusion Criteria:
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Anteroposterior LA diameter > 5.5 cm by TTE
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- Unstable angina
- Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) < 40%
- 2º (Type II) or 3º atrioventricular block
- Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Brugada syndrome
- Long QT syndrome
- Arrhythmogenic right ventricular dysplasia
- Sarcoidosis
- Hypertrophic cardiomyopathy
- Known cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- Any woman known to be pregnant
- Life expectancy less than one (1) year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
- Unwilling or unable to comply fully with study procedures and followup
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456949
Show 39 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456949
Show 39 Study Locations
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
| Principal Investigator: | Bradley P. Knight, MD, FACC, FHRS | Northwestern Memorial Hospital |
More Information
| Responsible Party: | Medtronic Atrial Fibrillation Solutions |
| ClinicalTrials.gov Identifier: | NCT01456949 History of Changes |
| Other Study ID Numbers: |
STOP AF PAS |
| Study First Received: | October 19, 2011 |
| Last Updated: | August 28, 2017 |
Keywords provided by Medtronic Atrial Fibrillation Solutions:
|
Atrial fibrillation (AF) Paroxysmal atrial fibrillation (PAF) Arrythmias |
Cardiac Arrythmias Cardiac ablation Cryoablation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 20, 2017