Trial Outcomes & Findings for Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation (NCT NCT02459574)
NCT ID: NCT02459574
Last Updated: 2024-10-09
Results Overview
Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
321 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Group 3-Conventional AF Ablation
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
103
|
110
|
|
Overall Study
COMPLETED
|
101
|
95
|
108
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
2
|
Reasons for withdrawal
| Measure |
Group 3-Conventional AF Ablation
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Missing BMI data for 4nr participants
Baseline characteristics by cohort
| Measure |
Group 3-Conventional AF Ablation
n=108 Participants
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=103 Participants
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=110 Participants
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 12.22 • n=108 Participants
|
60.5 years
STANDARD_DEVIATION 10.34 • n=103 Participants
|
60.1 years
STANDARD_DEVIATION 9.00 • n=110 Participants
|
60.1 years
STANDARD_DEVIATION 10.57 • n=321 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=108 Participants
|
46 Participants
n=103 Participants
|
46 Participants
n=110 Participants
|
134 Participants
n=321 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=108 Participants
|
57 Participants
n=103 Participants
|
64 Participants
n=110 Participants
|
187 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
3 Participants
n=108 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=110 Participants
|
4 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
1 Participants
n=108 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=110 Participants
|
1 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
0 Participants
n=108 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=110 Participants
|
1 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed
|
0 Participants
n=108 Participants
|
0 Participants
n=103 Participants
|
2 Participants
n=110 Participants
|
2 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
104 Participants
n=108 Participants
|
100 Participants
n=103 Participants
|
108 Participants
n=110 Participants
|
312 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=108 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=110 Participants
|
1 Participants
n=321 Participants
|
|
BMI (Body Mass Index)
|
28.88 kg/m^2
STANDARD_DEVIATION 4.670 • n=107 Participants • Missing BMI data for 4nr participants
|
27.98 kg/m^2
STANDARD_DEVIATION 4.830 • n=100 Participants • Missing BMI data for 4nr participants
|
29.12 kg/m^2
STANDARD_DEVIATION 5.040 • n=110 Participants • Missing BMI data for 4nr participants
|
28.68 kg/m^2
STANDARD_DEVIATION 4.860 • n=317 Participants • Missing BMI data for 4nr participants
|
|
No. with Hypertension
Non-Hypertensive
|
79 Participants
n=108 Participants
|
67 Participants
n=103 Participants
|
72 Participants
n=110 Participants
|
218 Participants
n=321 Participants
|
|
No. with Hypertension
Hypertensive
|
29 Participants
n=108 Participants
|
36 Participants
n=103 Participants
|
38 Participants
n=110 Participants
|
103 Participants
n=321 Participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
0
|
43 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
36 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
35 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
114 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
1
|
22 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
24 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
30 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
76 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
5
|
1 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
1 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
0 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
2 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
2
|
23 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
19 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
28 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
70 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
3
|
10 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
17 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
12 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
39 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
4
|
6 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
4 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
4 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
14 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
CHADSVASc Score (congestive heart failure, hypertension)
6
|
2 Participants
n=107 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
1 Participants
n=102 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
0 Participants
n=109 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
3 Participants
n=318 Participants • The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants
|
|
Ejection Fraction
|
58.3 %
STANDARD_DEVIATION 5.00 • n=93 Participants • 44 participants EJF missing at BL
|
57.9 %
STANDARD_DEVIATION 5.60 • n=93 Participants • 44 participants EJF missing at BL
|
57.1 %
STANDARD_DEVIATION 4.88 • n=91 Participants • 44 participants EJF missing at BL
|
57.8 %
STANDARD_DEVIATION 5.18 • n=277 Participants • 44 participants EJF missing at BL
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All randomized participants are eligible for ITT analysis - however, any patients that withdraw prior to first intervention cannot be assessed for the time-to-event based analysis
Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
Outcome measures
| Measure |
Group 3-Conventional AF Ablation
n=106 Participants
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=100 Participants
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=109 Participants
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
|
19 Participants
|
76 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full ITT Population
Composite outcome measure
Outcome measures
| Measure |
Group 3-Conventional AF Ablation
n=108 Participants
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=103 Participants
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=110 Participants
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Death or Stroke From Any Cause
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT Population
Composite outcome measure - Caused by the Procedure (Pericardial Effusion, Bleeding \>2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Outcome measures
| Measure |
Group 3-Conventional AF Ablation
n=108 Participants
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=103 Participants
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=110 Participants
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
All Events
|
3 participants
|
19 participants
|
7 participants
|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Drug Side Effect/Allergic Reaction
|
1 participants
|
18 participants
|
2 participants
|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Vascular Complication
|
1 participants
|
0 participants
|
3 participants
|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Cardiac Tamponade
|
0 participants
|
0 participants
|
2 participants
|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Phrenic Nerve Palsy
|
0 participants
|
0 participants
|
0 participants
|
|
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
TIA
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsComposite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia
Outcome measures
Outcome data not reported
Adverse Events
Group 3-Conventional AF Ablation
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 2-Anti-arrhythmic Therapy
Serious events: 12 serious events
Other events: 50 other events
Deaths: 1 deaths
Group 1-AVATAR-AF Ablation Protocol
Serious events: 13 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 3-Conventional AF Ablation
n=108 participants at risk
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=103 participants at risk
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=110 participants at risk
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Atrial Fibrillation/Flutter
|
1.9%
2/108 • Number of events 3 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
4.9%
5/103 • Number of events 5 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
4.5%
5/110 • Number of events 6 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Tamponade
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
1.8%
2/110 • Number of events 2 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Mass In Left Atrium
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Chest Pain
|
1.9%
2/108 • Number of events 2 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
2.9%
3/103 • Number of events 3 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Eye disorders
Bilateral Papilledema.
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Palpitation
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Nervous system disorders
Right Arm And Face Numbness
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.91%
1/110 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Musculoskeletal and connective tissue disorders
Injury To Right Hand
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia & Bronchospasm.
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Vascular disorders
Haemoptysis
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Investigations
Nose Surgery
|
0.00%
0/108 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.97%
1/103 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Injury, poisoning and procedural complications
Bleeding From Groin
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Musculoskeletal and connective tissue disorders
Pelvic Floor Repair
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Gastrointestinal disorders
Diverticulitis
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Injury, poisoning and procedural complications
Fractured Ribs, Cuts And Bruises.
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Strand Of Likely Thrombus Attached To Septum
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Surgical and medical procedures
Hip Replacement.
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Skin and subcutaneous tissue disorders
Femoral Entry Wound
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Nervous system disorders
Sciatica
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Surgical and medical procedures
Knee Replacement
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Bradycardia
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
TIA
|
0.93%
1/108 • Number of events 1 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/103 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
0.00%
0/110 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
Other adverse events
| Measure |
Group 3-Conventional AF Ablation
n=108 participants at risk
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Conventional AF ablation: Conventional ablation procedure
|
Group 2-Anti-arrhythmic Therapy
n=103 participants at risk
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
|
Group 1-AVATAR-AF Ablation Protocol
n=110 participants at risk
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
AVATAR-AF ablation: Experimental ablation protocol
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
6/108 • Number of events 7 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
10.7%
11/103 • Number of events 11 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
10.0%
11/110 • Number of events 16 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Cardiac disorders
Palpitations
|
3.7%
4/108 • Number of events 7 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
3.9%
4/103 • Number of events 4 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
5.5%
6/110 • Number of events 6 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
|
Investigations
All other events < 5% Freq
|
30.6%
33/108 • Number of events 57 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
40.8%
42/103 • Number of events 67 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
43.6%
48/110 • Number of events 75 • AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place