Trial Outcomes & Findings for nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation (NCT NCT01824394)
NCT ID: NCT01824394
Last Updated: 2025-02-04
Results Overview
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
481 participants
Primary outcome timeframe
30 days post-procedure
Results posted on
2025-02-04
Participant Flow
The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017.
This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization.
Participant milestones
| Measure |
nMARQ® Group
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
ThermoCool Group
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
|
Roll-in Subjects
Calibration roll-in cohort
|
|---|---|---|---|
|
Overall Study
STARTED
|
174
|
169
|
125
|
|
Overall Study
Intent to Treat Population
|
151
|
149
|
0
|
|
Overall Study
Safety Population
|
151
|
149
|
104
|
|
Overall Study
Per-Protocol Population
|
150
|
148
|
0
|
|
Overall Study
COMPLETED
|
55
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
119
|
116
|
74
|
Reasons for withdrawal
| Measure |
nMARQ® Group
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
ThermoCool Group
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
|
Roll-in Subjects
Calibration roll-in cohort
|
|---|---|---|---|
|
Overall Study
Early Termination
|
1
|
1
|
3
|
|
Overall Study
Withdrawn due to Study Termination
|
91
|
83
|
41
|
|
Overall Study
Lost to Follow-up
|
0
|
9
|
3
|
|
Overall Study
Death
|
3
|
2
|
4
|
|
Overall Study
Discontinued Subjects
|
1
|
1
|
2
|
|
Overall Study
Excluded Subjects(No catheter inserted)
|
23
|
20
|
21
|
Baseline Characteristics
Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
Baseline characteristics by cohort
| Measure |
nMARQ® Group
n=174 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
THERMOCOOL® Group
n=169 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
|
Roll-in Subjects
n=125 Participants
Calibration roll-in cohort
|
Total
n=468 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 10.81 • n=174 Participants • Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
|
61.8 Years
STANDARD_DEVIATION 10.40 • n=169 Participants • Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
|
63.6 Years
STANDARD_DEVIATION 9.96 • n=125 Participants • Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
|
62.4 Years
STANDARD_DEVIATION 10.41 • n=468 Participants • Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
|
|
Sex: Female, Male
Female
|
66 Participants
n=174 Participants • Enrolled subjects with data available.
|
60 Participants
n=169 Participants • Enrolled subjects with data available.
|
50 Participants
n=125 Participants • Enrolled subjects with data available.
|
176 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Sex: Female, Male
Male
|
108 Participants
n=174 Participants • Enrolled subjects with data available.
|
109 Participants
n=169 Participants • Enrolled subjects with data available.
|
75 Participants
n=125 Participants • Enrolled subjects with data available.
|
292 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=174 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
3 Participants
n=168 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
5 Participants
n=125 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
14 Participants
n=467 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=174 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
165 Participants
n=168 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
120 Participants
n=125 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
453 Participants
n=467 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
0 Participants
n=168 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
0 Participants
n=125 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
0 Participants
n=467 Participants • Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants • Enrolled subjects with data available.
|
2 Participants
n=169 Participants • Enrolled subjects with data available.
|
1 Participants
n=125 Participants • Enrolled subjects with data available.
|
3 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=174 Participants • Enrolled subjects with data available.
|
0 Participants
n=169 Participants • Enrolled subjects with data available.
|
1 Participants
n=125 Participants • Enrolled subjects with data available.
|
3 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants • Enrolled subjects with data available.
|
0 Participants
n=169 Participants • Enrolled subjects with data available.
|
0 Participants
n=125 Participants • Enrolled subjects with data available.
|
0 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=174 Participants • Enrolled subjects with data available.
|
0 Participants
n=169 Participants • Enrolled subjects with data available.
|
0 Participants
n=125 Participants • Enrolled subjects with data available.
|
2 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
White
|
169 Participants
n=174 Participants • Enrolled subjects with data available.
|
165 Participants
n=169 Participants • Enrolled subjects with data available.
|
121 Participants
n=125 Participants • Enrolled subjects with data available.
|
455 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants • Enrolled subjects with data available.
|
0 Participants
n=169 Participants • Enrolled subjects with data available.
|
0 Participants
n=125 Participants • Enrolled subjects with data available.
|
0 Participants
n=468 Participants • Enrolled subjects with data available.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=174 Participants • Enrolled subjects with data available.
|
2 Participants
n=169 Participants • Enrolled subjects with data available.
|
2 Participants
n=125 Participants • Enrolled subjects with data available.
|
5 Participants
n=468 Participants • Enrolled subjects with data available.
|
PRIMARY outcome
Timeframe: 30 days post-procedurePopulation: Safety Population
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Outcome measures
| Measure |
nMARQ® Group
n=151 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
ThermoCool Group
n=149 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
|
Roll-in Subjects
n=104 Participants
Calibration roll-in cohort
|
|---|---|---|---|
|
Number of Participants With Early Onset Primary Adverse Events
|
8 Participants
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 30 days post-procedurePopulation: The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Outcome measures
| Measure |
nMARQ® Group
n=151 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
ThermoCool Group
n=149 Participants
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
|
Roll-in Subjects
Calibration roll-in cohort
|
|---|---|---|---|
|
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
|
8 Participants
|
7 Participants
|
—
|
Adverse Events
nMARQ® Group
Serious events: 38 serious events
Other events: 86 other events
Deaths: 3 deaths
THERMOCOOL® Group
Serious events: 25 serious events
Other events: 86 other events
Deaths: 2 deaths
Roll-in Subjects
Serious events: 31 serious events
Other events: 74 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
nMARQ® Group
n=151 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
THERMOCOOL® Group
n=149 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter
|
Roll-in Subjects
n=104 participants at risk
Calibration roll-in cohort
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia (in remission)
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 5 • 3 years post ablation procedures
|
|
Cardiac disorders
Atrial flutter
|
4.0%
6/151 • Number of events 11 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 3 • 3 years post ablation procedures
|
|
Cardiac disorders
Atrioventricular block
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Cardiac arrest
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Chest pain
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 4 • 3 years post ablation procedures
|
|
Cardiac disorders
Fluid overload
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Palpitations
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
3/151 • Number of events 3 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Pericarditis
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Presyncope
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Cardiac disorders
Pulmonary oedema
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Syncope
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Tachycardia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 3 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Endocrine disorders
Goitre
|
0.66%
1/151 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Colon cancer
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Enterocele
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Rectal cancer
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
General disorders
Chest discomfort
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
General disorders
Device dislocation
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 2 • 3 years post ablation procedures
|
|
General disorders
Device related infection
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
General disorders
Implant site infection
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
General disorders
Pyrexia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Hepatobiliary disorders
Hepatic cancer metastatic
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Immune system disorders
Asthma
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Infections and infestations
Bronchitis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Infections and infestations
Cystitis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Infections and infestations
Pneumonia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 3 • 3 years post ablation procedures
|
|
Infections and infestations
Sepsis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Investigations
Blood sodium decreased
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Investigations
Heart rate increased
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Investigations
International normalised ratio increased
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Metabolism and nutrition disorders
Respiratory failure
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Nervous system disorders
Dizziness
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Renal and urinary disorders
Haematuria
|
0.66%
1/151 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Explorative laparotomy
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Meniscus operation
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Arteriovenous fistula
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Embolism
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Haematoma
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/151 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Vessel puncture site haemorrhage
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Carotid artery stenosis
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
Other adverse events
| Measure |
nMARQ® Group
n=151 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
|
THERMOCOOL® Group
n=149 participants at risk
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter
|
Roll-in Subjects
n=104 participants at risk
Calibration roll-in cohort
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Contusion
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/151 • Number of events 3 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Atrial flutter
|
1.3%
2/151 • Number of events 6 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 8 • 3 years post ablation procedures
|
|
Cardiac disorders
Bradycardia
|
2.6%
4/151 • Number of events 4 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Chest pain
|
0.66%
1/151 • Number of events 10 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 11 • 3 years post ablation procedures
|
5.8%
6/104 • Number of events 9 • 3 years post ablation procedures
|
|
Cardiac disorders
Dyspnoea
|
2.0%
3/151 • Number of events 3 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Fluid overload
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Oedema peripheral
|
1.3%
2/151 • Number of events 3 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 3 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Palpitations
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Pericardial effusion
|
4.0%
6/151 • Number of events 6 • 3 years post ablation procedures
|
2.7%
4/149 • Number of events 4 • 3 years post ablation procedures
|
6.7%
7/104 • Number of events 7 • 3 years post ablation procedures
|
|
Cardiac disorders
Presyncope
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 4 • 3 years post ablation procedures
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Cardiac disorders
Syncope
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Cardiac disorders
Tachycardia
|
3.3%
5/151 • Number of events 5 • 3 years post ablation procedures
|
2.7%
4/149 • Number of events 4 • 3 years post ablation procedures
|
4.8%
5/104 • Number of events 6 • 3 years post ablation procedures
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Eye disorders
Cataract
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Eye disorders
Visual impairment
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Eye disorders
Corneal abrasionCorneal abrasion
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Nausea
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Gastrointestinal disorders
Oesophageal injury
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
General disorders
Chest discomfort
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 3 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
General disorders
Fatigue
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 3 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
General disorders
Pyrexia
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
2.7%
4/149 • Number of events 4 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
General disorders
Vessel puncture site haematoma
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
2.9%
3/104 • Number of events 3 • 3 years post ablation procedures
|
|
Immune system disorders
Hypersensitivity
|
3.3%
5/151 • Number of events 5 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Infections and infestations
Bronchitis
|
2.6%
4/151 • Number of events 4 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 5 • 3 years post ablation procedures
|
|
Infections and infestations
Influenza
|
0.00%
0/151 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Infections and infestations
Localised infection
|
2.0%
3/151 • Number of events 4 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 2 • 3 years post ablation procedures
|
|
Infections and infestations
Pneumonia
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Infections and infestations
Sinusitis
|
2.6%
4/151 • Number of events 4 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 4 • 3 years post ablation procedures
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/151 • Number of events 10 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 4 • 3 years post ablation procedures
|
|
Investigations
Heart rate increased
|
0.00%
0/151 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/151 • Number of events 3 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.67%
1/149 • Number of events 1 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
4/151 • Number of events 5 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Nervous system disorders
Dysphonia
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Nervous system disorders
Headache
|
2.0%
3/151 • Number of events 4 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/151 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Nervous system disorders
Sleep apnoea syndrome
|
3.3%
5/151 • Number of events 5 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
3.8%
4/104 • Number of events 4 • 3 years post ablation procedures
|
|
Nervous system disorders
Dizziness
|
0.00%
0/151 • 3 years post ablation procedures
|
2.0%
3/149 • Number of events 3 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Renal and urinary disorders
Haematuria
|
2.6%
4/151 • Number of events 4 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Renal and urinary disorders
Renal failure acute
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
1.9%
2/104 • Number of events 2 • 3 years post ablation procedures
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/149 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Vascular disorders
Haematoma
|
0.66%
1/151 • Number of events 11 • 3 years post ablation procedures
|
4.7%
7/149 • Number of events 7 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
|
Vascular disorders
Haemorrhage
|
0.66%
1/151 • Number of events 1 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.00%
0/104 • 3 years post ablation procedures
|
|
Vascular disorders
Hypertension
|
6.0%
9/151 • Number of events 10 • 3 years post ablation procedures
|
5.4%
8/149 • Number of events 9 • 3 years post ablation procedures
|
6.7%
7/104 • Number of events 8 • 3 years post ablation procedures
|
|
Vascular disorders
Hypotension
|
1.3%
2/151 • Number of events 2 • 3 years post ablation procedures
|
1.3%
2/149 • Number of events 2 • 3 years post ablation procedures
|
0.96%
1/104 • Number of events 1 • 3 years post ablation procedures
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for 60 to 180 days from the time submitted to the sponsor for review. For multicenter studies, the first results communications should be a joint multicenter publication. PIs may communicate results from their institution as indicated above if a multicenter publication is not submitted by the Sponsor or representatives within 12 months of the study's conclusion.
- Publication restrictions are in place
Restriction type: OTHER