Trial Outcomes & Findings for STOP Persistent AF (NCT NCT03012841)
NCT ID: NCT03012841
Last Updated: 2025-02-13
Results Overview
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
COMPLETED
NA
186 participants
12 Months
2025-02-13
Participant Flow
Participant milestones
| Measure |
Modified Intent to Treat (mITT) Group
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
Not Treated
Subjects enrolled, but not treated with an Arctic Front Advance Cryoablation catheter.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
21
|
|
Overall Study
COMPLETED
|
145
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
21
|
Reasons for withdrawal
| Measure |
Modified Intent to Treat (mITT) Group
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
Not Treated
Subjects enrolled, but not treated with an Arctic Front Advance Cryoablation catheter.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
10
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Unable to complete 12 month visit
|
6
|
0
|
|
Overall Study
Subject relocation
|
1
|
0
|
|
Overall Study
Seasonal winter travel
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
No ablation performed
|
0
|
2
|
|
Overall Study
Study reached n=165 treated subject cap
|
0
|
5
|
|
Overall Study
Insurance change
|
0
|
1
|
Baseline Characteristics
STOP Persistent AF
Baseline characteristics by cohort
| Measure |
Modified Intent to Treat Group (mITT)
n=165 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Subject/physician chose not to provide
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
15 participants
n=5 Participants
|
|
Time from Persistent Atrial Fibrillation (AF) Onset
|
0.6 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Duration of Longest Persistent AF Episode
|
60.9 days
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsTreatment 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
Outcome measures
| Measure |
Modified Intent to Treat Group (mITT)
n=165 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
|
54.8 percentage of participants
Interval 46.7 to 62.1
|
PRIMARY outcome
Timeframe: 12 monthsA 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)
Outcome measures
| Measure |
Modified Intent to Treat Group (mITT)
n=165 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
|
0.6 percentage of participants
Interval 0.1 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Treated subjects completing at least 50% of questions on AFEQT questionnaires at both baseline and 12-month visits
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).
Outcome measures
| Measure |
Modified Intent to Treat Group (mITT)
n=141 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
|
25.8 score on a scale
Interval 22.1 to 29.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits
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).
Outcome measures
| Measure |
Modified Intent to Treat Group (mITT)
n=142 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component
|
5.0 score on a scale
Interval 3.5 to 6.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits
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).
Outcome measures
| Measure |
Modified Intent to Treat Group (mITT)
n=142 Participants
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
|
|---|---|
|
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component
|
4.9 score on a scale
Interval 3.2 to 6.6
|
Adverse Events
Enrolled Subjects
Serious adverse events
| Measure |
Enrolled Subjects
n=186 participants at risk
All enrolled and consented subjects
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.4%
10/186 • Number of events 11 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/186 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.1%
2/186 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Angina pectoris
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Vascular disorders
Aortic perforation
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Atrial tachycardia
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Bacterial sepsis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Bronchitis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Cardiac failure
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Cardiac failure acute
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Gastrointestinal disorders
Crohn's disease
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Diverticulitis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Nervous system disorders
Hemiparesis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Herpes zoster
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Vascular disorders
Hypertension
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Labyrinthitis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Gastrointestinal disorders
Odynophagia
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Pericarditis
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Pneumonia
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
General disorders
Puncture site haematoma
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Gastrointestinal disorders
Vomiting
|
0.54%
1/186 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
Other adverse events
| Measure |
Enrolled Subjects
n=186 participants at risk
All enrolled and consented subjects
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
23.7%
44/186 • Number of events 62 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
|
Cardiac disorders
Atrial flutter
|
10.8%
20/186 • Number of events 24 • All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principle Investigator (PI) agrees they will not independently discuss or publish trial results until a multi-center publication is released. If a multi-center publication is not released within one year after completion of the Study at all Study sites, PIs will have the right to publish the results of and information pertaining to their activities. Any such Publication must be submitted to Medtronic for review and comment at least sixty (60) days prior to submission or presentation.
- Publication restrictions are in place
Restriction type: OTHER