STOP Persistent AF

NCT03012841 | Completed Results FDA Device

• 1 other identifier: STOP Persistent AF
• Study Type: interventional
• Target: 186
• Locations: 3 countries
• Sites: 25

Brief 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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)

  Baseline and 12 months

• Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component

  Baseline and 12 months

• Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component

  Baseline and 12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter

Device: Arctic Front Advance Cardiac CryoAblation Catheter

Interventions

Arctic Front Advance Cardiac CryoAblation Catheter DEVICE

Cryoablation

Also known as: Freezor MAX Cardiac CryoAblation Catheter

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (25)

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Cardiac Arrhythmia Service

Boca Raton, Florida, 33432, United States

Location

Saint Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201-1718, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287-0005, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Englewood Hospital & Medical Center

Englewood, New Jersey, 07631-1808, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)

New York, New York, 10075-1851, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Baylor Research Institute

Dallas, Texas, 75226, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8T 1Z4, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Tokyo Medical and Dental University

Bunkyō, Tokyo, 113-8519, Japan

Location

Jikei University Hospital

Tokyo, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, 231-8682, Japan

Location

Related Publications (1)

• 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.

  PMID: 32590151 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mary Sauline, Clinical Research Specialist
• Organization: Medtronic

mary.k.sauline@medtronic.com

440-596-3529

Study Officials

• Hugh Calkins, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 6, 2017
• Study Start: March 2, 2017
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: February 13, 2025
• Results First Posted: August 21, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3); US (19); CA (3)