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Catheter Ablation

STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation (STOP AF First Trial)

N/A
Waitlist Available
Led By Steve Nissen, MD
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
No Placebo-Only Group

Summary

To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.
Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
Secondary study objectives
Healthcare Utilization
Quality of Life Scores at Baseline Compared to 12 Months

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT04118166
50%
Other, Disease Progression (death)
30%
Fatigue
23%
Cough
17%
Constipation
17%
Nausea
17%
Pruritis
13%
Anemia
13%
Hypothyroidism
13%
Abdominal pain
13%
Fever
13%
Weight loss
13%
Rash
10%
Dyspnea
10%
Productive cough
10%
Hyperthyroidism
10%
Diarrhea
10%
Other, Decreased appetite
7%
Abdominal bloating
7%
Headache
7%
Elevated ALT
7%
Elevated AST
7%
Intermittent heart palpitations
7%
Tachycardia
7%
Dry mouth
7%
Intermittent nausea
7%
Hyponatremia
7%
Other, Pain to right chest wall at recent site of cryo
7%
Wheezing
3%
UTI
3%
Allergic reaction
3%
Neuropathy under R axilla
3%
Nasal congestion
3%
Other, Motor deficit, right side
3%
L eye pain
3%
Hiccups
3%
Pain
3%
Other, Intermittent left sciatic pain
3%
Intermittent brief blurry vision
3%
Other, Lack of appetite
3%
Other, Occasional twitching sensation to anterior chest wall
3%
Insomnia
3%
Pneumonitis
3%
Right neck pain
3%
Worsening anxiety
3%
Other, Neuropathic pain
3%
Gum infection
3%
Dizziness
3%
Shortness of breath with exertion
3%
Pneumothorax
3%
Hoarse voice
3%
Peripheral sensory neuropathy
3%
Muscle weakness, left-sided
3%
Respiratory failure
3%
Anxiety
3%
Other, Motor deficit, left side
3%
Arthralgias
3%
Other, Corneal abrasion
3%
L eye redness
3%
Confusion
3%
Other, Intermittent bilateral hand numbness
3%
Lower back throbbing pain
3%
Right shoulder pain (Pain in extremity)
3%
Pleural effusion
3%
Arthritis
3%
Right pleural effusion
3%
Chest wall pain
3%
Intermittent chills followed by hot flashes
3%
Muscle weakness
3%
Muscle weakness, right-sided
3%
Other, Infectious diarrhea
3%
Right apical pneumothorax
3%
Intermittent abdominal bloating
3%
Worsening left leg weakness
3%
Muscle and joint aches
3%
Worsening cough
3%
Right pneumothorax
3%
Chest Pain
3%
Keratitis
3%
Tension pneumothorax (requiring ICU stay)
3%
Depression
3%
Sore throat
3%
Cardiac arrest
3%
Adrenal insufficiency
3%
Blood bilirubin increased
3%
Alkaline phosphatase increased
3%
Hematuria
3%
Proteinuria
3%
Intermittent bronchopulmonary hemorrhage
3%
Shortness of breath
3%
Hypoxia
3%
Other, Deep vein thrombois (DVT) of catheter
3%
Atrial fibrillation
3%
Pericarditis
3%
Sinus tachycardia
3%
Other, Decreased pulse
3%
Ringing in the ears (tinnitus)
3%
Hypophysitis
3%
Dry eyes
3%
Flashing lights
3%
L eye burning sensation
3%
L eye blurred vision
3%
R eye blurred vision
3%
Increased abdominal pain
3%
Diarrhea (intermittent)
3%
Intermittent nausea/vomiting
3%
Vomiting
3%
Other, Mucositis
3%
Intermittent fever
3%
Low grade fever
3%
Flu-like symptoms
3%
Intermittent chest pain to R sternal border exacerbated with deep inhalation
3%
Intermittent fatigue
3%
Other, Presumed pneumonia
3%
Fall
3%
Creatinine increased
3%
Elevated TSH
3%
TSH increased
3%
Decreased WBC count
3%
Anorexia
3%
Other, Gluteal pain and swelling
3%
Other, Arm pain left
3%
Other, Muscle aches and fatigue associated with COVID vaccine
3%
Other, Right thigh pain
3%
Other, Soreness to right lateral ribs
3%
Other, Soreness at site of recent cryoablation (R lung)
3%
Other, Soreness right chest wall
3%
Other, Soreness to left side at site of recent cryoablation
3%
Other, Soreness, right shoulder
3%
Other, Pelvic bone pain
3%
Other, Intermittent peripheral edema
3%
Other, Weakness to left shoulder
3%
Intermittent hematuria
3%
Blood tinge sputum
3%
Intermittent cough
3%
Intermittent cough w/chest tightness
3%
Intermittent cough with Blood tinge sputum
3%
Dry cough
3%
Other, Hair thinning
3%
Other, Leg ulcer left
3%
Other, Molluscum contagiousum on left arm
3%
Pulmonary embolism
3%
Upper respiratory infection (COVID-19)
3%
Intermittent wheezing
3%
Other, Hemoptysis
3%
Dry skin
3%
Facial rash
3%
Maculo-papular rash
3%
Maculo-papular rash to bilateral arms
3%
Post-inflammatory hyperpigmentation on left breast
3%
Tinea
3%
Other, Burned hand
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ipilimumab/Nivolumab + Cryotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CryoablationExperimental Treatment1 Intervention
Group II: Anti-arrhythmic drugActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2017
Completed Phase 2
~1030

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
205 Previous Clinical Trials
136,594 Total Patients Enrolled
44 Trials studying Atrial Fibrillation
22,095 Patients Enrolled for Atrial Fibrillation
Steve Nissen, MDPrincipal InvestigatorThe Cleveland Clinic
Gopi Dandamudi, MDPrincipal InvestigatorFranciscan Heart & Vascular Associates at St. Joseph
1 Previous Clinical Trials
234 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
234 Patients Enrolled for Atrial Fibrillation
Oussama Wazni, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
1,888 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
1,888 Patients Enrolled for Atrial Fibrillation
~26 spots leftby Dec 2025
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