N/A
N=186
STOP Persistent AF
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03012841 ↗Enrolled (actual)
186
Serious AEs
18.3%
Results posted
Aug 2020
Primary outcome: Primary: Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. — 54.8 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arctic Front Advance Cardiac CryoAblation Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. |
54.8 | <0.001 sig |
| PRIMARY Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. |
0.6 | 0.002 sig |
| SECONDARY Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) |
25.8 | <0.001 sig |
| SECONDARY Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component |
5.0 | <0.001 sig |
| SECONDARY Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component |
4.9 | <0.001 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
- Failure or intolerance of at least one Class I or III antiarrhythmic drug
- Age 18 or older (or older than 18 if required by local law)
Exclusion Criteria
- Left atrial diameter > 5.0 cm (anteroposterior)
- Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Presence of any cardiac valve prosthesis
- +3 and +4 mitral valve regurgitation or stenosis
- Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
- Unstable angina
- New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
- Primary pulmonary hypertension
- Rheumatic heart disease
- Thrombocytosis, thrombocytopenia
- Any condition contraindicating chronic anticoagulation
- Active systemic infection
- Hypertrophic cardiomyopathy
- Cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
- Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
- Life expectancy less than one year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- Known allergies or hypersensitivities to adhesives
- Known drug or alcohol dependency
- Unwilling or unable to comply fully with study procedures and follow-up
Data sourced from ClinicalTrials.gov (NCT03012841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.