STOP Persistent AF

Atrial Fibrillation Clinical Trial

Official title:

STOP Persistent AF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012841
• Other study ID #: STOP Persistent AF
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: August 13, 2019

Study information

• Verified date: September 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Arctic Front Advance Cardiac CryoAblation Catheter
Cryoablation

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia
Japan	Tokyo Medical and Dental University	Bunkyo	Tokyo
Japan	Jikei University Hospital	Tokyo
Japan	Yokohama City Minato Red Cross Hospital	Yokohama
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Cardiac Arrhythmia Service	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Baylor Research Institute	Dallas	Texas
United States	Doylestown Health Cardiology	Doylestown	Pennsylvania
United States	Englewood Hospital & Medical Center	Englewood	New Jersey
United States	NorthShore University Health System	Evanston	Illinois
United States	Saint Vincent's Medical Center	Jacksonville	Florida
United States	St. Luke's Health System	Kansas City	Missouri
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)	New York	New York
United States	Banner-University Medical Center Phoenix	Phoenix	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: Acute procedural failure; Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period; A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period; Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.; Ablation using radiofrequency (RF) in the left atrium; Blanking period is defined as the first 90 days after the index ablation procedure.; Acute procedural failure is defined as: Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure; Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers	12 Months
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: Transient ischemic attack (within 7 days of ablation procedure); Cerebrovascular accident (within 7 days of ablation procedure); Major bleeding that requires transfusion (within 7 days of ablation procedure); Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure); Pulmonary vein stenosis (> 75% reduction within 12-months of ablation procedure); Myocardial infarction (within 7 days of ablation procedure); Phrenic nerve injury (unresolved at 12-months); Atrio-esophageal fistula (within 12-months of ablation procedure); Death (within 7 days of ablation procedure)	12 months
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).	Baseline and 12 months
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).	Baseline and 12 months
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).	Baseline and 12 months