Trial Outcomes & Findings for NAVISTAR® THERMOCOOL® Catheter Post Approval Registry (NCT NCT00964392)
NCT ID: NCT00964392
Last Updated: 2025-02-04
Results Overview
The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
437 participants
Primary outcome timeframe
Seven days post ablation procedure
Results posted on
2025-02-04
Participant Flow
The first subject was enrolled on September 29, 2009. Subject enrollment was completed and closed on October 01, 2013 after reaching a total of 437 enrolled (381 evaluable) subjects. The study is still ongoing. This report covers data up to the data download of June 23, 2015.
Participant milestones
| Measure |
More-Experienced Physicians (MEP)
MEP are defined as those who have performed greater than 50 AF ablation cases per year.
|
Less-Experienced Physicians (LEP)
LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
282
|
|
Overall Study
COMPLETED
|
72
|
92
|
|
Overall Study
NOT COMPLETED
|
53
|
190
|
Reasons for withdrawal
| Measure |
More-Experienced Physicians (MEP)
MEP are defined as those who have performed greater than 50 AF ablation cases per year.
|
Less-Experienced Physicians (LEP)
LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
|
Overall Study
Early Termination, non-study arrhythmia
|
1
|
6
|
|
Overall Study
Not completed
|
44
|
168
|
Baseline Characteristics
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Baseline characteristics by cohort
| Measure |
More-experienced Physicians
n=128 Participants
Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
|
Less-experienced Physicians
n=292 Participants
Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
410 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=5 Participants
|
292 participants
n=7 Participants
|
420 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Seven days post ablation procedurePopulation: Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one primary AE, was excluded from this analysis since the subject discontinued prior to RF ablation.
The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.
Outcome measures
| Measure |
More-experienced Physicians
n=125 Participants
Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
|
Less-experienced Physicians
n=282 Participants
Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
|
|---|---|---|
|
The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.
|
3.2 percentage of participants
Interval 0.0 to 7.2
|
6.4 percentage of participants
Interval 0.0 to 9.3
|
SECONDARY outcome
Timeframe: First study day to 5 year post-ablationPopulation: Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one SAE, was excluded from this analysis since the subject discontinued prior to RF ablation.
The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).
Outcome measures
| Measure |
More-experienced Physicians
n=125 Participants
Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
|
Less-experienced Physicians
n=282 Participants
Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
|
|---|---|---|
|
Percentage of Subjects Experienced Serious Adverse Events.
1 to 30 days post-ablation
|
6.4 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Subjects Experienced Serious Adverse Events.
31 days to 365 days post-ablation
|
11.2 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Subjects Experienced Serious Adverse Events.
366 to 730 days post-ablation
|
14.9 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Subjects Experienced Serious Adverse Events.
More than 730 days post-ablation
|
11.0 percentage of participants
|
11.1 percentage of participants
|
Adverse Events
More-experienced Physicians
Serious events: 41 serious events
Other events: 78 other events
Deaths: 0 deaths
Less-experienced Physicians
Serious events: 95 serious events
Other events: 168 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
More-experienced Physicians
n=125 participants at risk
Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
|
Less-experienced Physicians
n=282 participants at risk
Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
4/125 • Number of events 4 • Five years post-ablation
|
2.5%
7/282 • Number of events 7 • Five years post-ablation
|
|
Cardiac disorders
Atrial flutter
|
4.0%
5/125 • Number of events 7 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Cardiac disorders
Pericardial effusion
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
2.1%
6/282 • Number of events 6 • Five years post-ablation
|
|
Cardiac disorders
Chest pain
|
3.2%
4/125 • Number of events 6 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Cardiac disorders
Atrial tachycardia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.1%
3/282 • Number of events 8 • Five years post-ablation
|
|
Cardiac disorders
Bradycardia
|
3.2%
4/125 • Number of events 4 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Syncope
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Cardiac disorders
Ventricular tachycardia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Cardiac disorders
Dyspnoea
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Fluid overload
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Sick sinus syndrome
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Angina unstable
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Cardiac failure congestive
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Cardiac procedure complication
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Dizziness
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Dressler's syndrome
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Palpitations
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Presyncope
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Endocrine disorders
Gastrinoma
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Oesophageal injury
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Alcohol withdrawal syndrome
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Device dislocation
|
0.80%
1/125 • Number of events 2 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Device related infection
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Injection site haematoma
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Non-cardiac chest pain
|
0.80%
1/125 • Number of events 2 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Pyrexia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Pneumonia
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
1.4%
4/282 • Number of events 5 • Five years post-ablation
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Urosepsis
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Biopsy thyroid gland abnormal
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Investigations
Cardiac pacemaker evaluation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Cardiac stress test abnormal
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Investigations
Heart rate increased
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Investigations
International normalised ratio increased
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Smear cervix abnormal
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Brain mass
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Migraine
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Transient ischaemic attack
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Renal failure acute
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Knee arthroplasty
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
1.1%
3/282 • Number of events 4 • Five years post-ablation
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Cancer surgery
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Cryotherapy
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Debridement
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Obesity surgery
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Packed red blood cell transfusion
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Haematoma
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Vascular disorders
Hypotension
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Vascular disorders
Artery dissection
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
Other adverse events
| Measure |
More-experienced Physicians
n=125 participants at risk
Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
|
Less-experienced Physicians
n=282 participants at risk
Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Blood and lymphatic system disorders
Ecchymosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Atrial fibrillation
|
22.4%
28/125 • Number of events 44 • Five years post-ablation
|
15.6%
44/282 • Number of events 60 • Five years post-ablation
|
|
Cardiac disorders
Atrial flutter
|
3.2%
4/125 • Number of events 4 • Five years post-ablation
|
5.0%
14/282 • Number of events 20 • Five years post-ablation
|
|
Cardiac disorders
Chest pain
|
3.2%
4/125 • Number of events 5 • Five years post-ablation
|
4.6%
13/282 • Number of events 16 • Five years post-ablation
|
|
Cardiac disorders
Atrial tachycardia
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
2.8%
8/282 • Number of events 9 • Five years post-ablation
|
|
Cardiac disorders
Palpitations
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
2.5%
7/282 • Number of events 8 • Five years post-ablation
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
2.1%
6/282 • Number of events 6 • Five years post-ablation
|
|
Cardiac disorders
Dyspnoea
|
3.2%
4/125 • Number of events 5 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Cardiac disorders
Chest discomfort
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Cardiac disorders
Dizziness
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Cardiac disorders
Arrhythmia
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Oedema peripheral
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Dyspnoea exertional
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Syncope
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Fluid overload
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Bradycardia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Cardiac failure congestive
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Cardiac flutter
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Cardiac disorders
Cardiac procedure complication
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Pulmonary oedema
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 2 • Five years post-ablation
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Ear and labyrinth disorders
Vertigo
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Endocrine disorders
Hyperthyroidism
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Endocrine disorders
Basedow's disease
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Endocrine disorders
Hypothyroidism
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Endocrine disorders
Thyroid neoplasm
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Eye disorders
Vision blurred
|
0.00%
0/125 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Eye disorders
Ocular hyperaemia
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Eye disorders
Conjunctival haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Eye disorders
Periorbital haemorrhage
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Eye disorders
Scleral haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Eye disorders
Visual impairment
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/125 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Haematochezia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Procedural nausea
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Fungal oesophagitis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 2 • Five years post-ablation
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Haematemesis
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Pancreatic carcinoma
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Procedural vomiting
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Tongue biting
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Vessel puncture site haematoma
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
General disorders
Procedural pain
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
General disorders
Fatigue
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
General disorders
Pyrexia
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
General disorders
Vessel puncture site haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Adverse drug reaction
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Device malfunction
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Device power source issue
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Drug intolerance
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Flank pain
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Infusion related reaction
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Injection site haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Mass
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
General disorders
Non-cardiac chest pain
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Oedema
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Swelling
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
General disorders
Wound secretion
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Hepatobiliary disorders
Cholecystitis infective
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
2.1%
6/282 • Number of events 8 • Five years post-ablation
|
|
Infections and infestations
Herpes zoster
|
1.6%
2/125 • Number of events 3 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Infections and infestations
Sinusitis
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Pneumonia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Cellulitis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Influenza
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Lung infection
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Median nerve injury
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Nerve compression
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Heart rate increased
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Blood pressure decreased
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Blood pressure increased
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Investigations
Blood urine present
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Culture urine positive
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Echocardiogram
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Endoscopy upper gastrointestinal tract normal
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Investigations
Prostatic specific antigen increased
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Investigations
Sinus rhythm
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
3/125 • Number of events 3 • Five years post-ablation
|
2.5%
7/282 • Number of events 7 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/125 • Five years post-ablation
|
2.5%
7/282 • Number of events 7 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Cervicobrachial syndrome
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cyst
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Headache
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Nervous system disorders
Dysarthria
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Nervous system disorders
Agitation
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Nervous system disorders
Dysphonia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Insomnia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Nervous system disorders
Sleep apnoea syndrome
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Dysuria
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
2.5%
7/282 • Number of events 7 • Five years post-ablation
|
|
Renal and urinary disorders
Haematuria
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 2 • Five years post-ablation
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
2.1%
6/282 • Number of events 7 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/125 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
0.00%
0/125 • Five years post-ablation
|
1.4%
4/282 • Number of events 4 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/125 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
1.1%
3/282 • Number of events 3 • Five years post-ablation
|
|
Surgical and medical procedures
Cardiac ablation
|
4.0%
5/125 • Number of events 5 • Five years post-ablation
|
2.5%
7/282 • Number of events 8 • Five years post-ablation
|
|
Surgical and medical procedures
Cardioversion
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
1.8%
5/282 • Number of events 6 • Five years post-ablation
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/125 • Five years post-ablation
|
0.71%
2/282 • Number of events 5 • Five years post-ablation
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
High frequency ablation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Incisional drainage
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.00%
0/282 • Five years post-ablation
|
|
Vascular disorders
Haematoma
|
3.2%
4/125 • Number of events 4 • Five years post-ablation
|
2.1%
6/282 • Number of events 6 • Five years post-ablation
|
|
Vascular disorders
Arteriovenous fistula
|
1.6%
2/125 • Number of events 2 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Hypotension
|
0.80%
1/125 • Number of events 1 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Hypertension
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/125 • Five years post-ablation
|
0.35%
1/282 • Number of events 1 • Five years post-ablation
|
Additional Information
Robert Stagg, Clinical Franchise
Biosense Webster, Inc.
Phone: (800) 729-9010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
- Publication restrictions are in place
Restriction type: OTHER