Trial Outcomes & Findings for Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation (NCT NCT00926783)
NCT ID: NCT00926783
Last Updated: 2014-06-10
Results Overview
Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
From day 91 to day 365 post first ablation procedure
Results posted on
2014-06-10
Participant Flow
The first subject of the study was consented on August 17, 2009. The final follow-up was performed on November 14, 2011. The total study duration was approximately 27 months. A total of 86 subjects were enrolled from 7 participating sites; 2 sites in the United States (US), 4 sites in Canada, and 1 site in Australia.
Among the 86 consented subjects, two were excluded prior to randomization; one was excluded due to thrombus found on pre-procedure echo. Hence only 83 subjects were randomized to the two treatment arms and underwent radio-frequency ablation
Participant milestones
| Measure |
Targeted CFAE Ablation
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Targeted CFAE Ablation
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Overall Study
Incomplete CFAE Procedures
|
3
|
3
|
Baseline Characteristics
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Targeted CFAE Ablation
n=42 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=40 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Atrial fibrillation type
High Burden Paroxysmal
|
11 participants
n=5 Participants
|
19 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Atrial fibrillation type
Persistent
|
31 participants
n=5 Participants
|
21 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Duration of Atrial fibrillation diagnosis (Year)
|
5.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
5.5 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: From day 91 to day 365 post first ablation procedurePopulation: Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures.
Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.
Outcome measures
| Measure |
Targeted CFAE Ablation
n=39 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=38 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.
Without recurrence AF/AFL/AT
|
10 participants
|
18 participants
|
|
Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.
With recurrence AF/AFL/AT
|
29 participants
|
20 participants
|
PRIMARY outcome
Timeframe: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.
Outcome measures
| Measure |
Targeted CFAE Ablation
n=39 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=37 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Total Radio-frequency (RF) Delivery Time During CFAE
|
23.2 Minutes
Standard Deviation 19.7
|
37.8 Minutes
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Duration of ablation procedure (up to about 5 hours)Population: Per-protocol population with available outcome data
Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.
Outcome measures
| Measure |
Targeted CFAE Ablation
n=39 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=38 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Duration of Ablation Procedure
Total Procedure Time
|
220.6 Minutes
Standard Deviation 59.4
|
226.1 Minutes
Standard Deviation 52.0
|
|
Duration of Ablation Procedure
Procedure Time to Access Site
|
42.7 Minutes
Standard Deviation 20.8
|
45.4 Minutes
Standard Deviation 22.4
|
|
Duration of Ablation Procedure
Procedure Time to Mapping
|
35.7 Minutes
Standard Deviation 26.5
|
27.4 Minutes
Standard Deviation 10.5
|
|
Duration of Ablation Procedure
Procedure Time to Ablation and Verification
|
132.8 Minutes
Standard Deviation 43.0
|
149.9 Minutes
Standard Deviation 47.7
|
SECONDARY outcome
Timeframe: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)Population: Per-protocol population with available outcome data
Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms. Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis.
Outcome measures
| Measure |
Targeted CFAE Ablation
n=39 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=38 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Fluoroscopy Time
Total Fluoroscopy Time
|
57.4 Minutes
Standard Deviation 20.2
|
60.1 Minutes
Standard Deviation 19.3
|
|
Fluoroscopy Time
Fluoroscopy Time to Gain Access
|
9.7 Minutes
Standard Deviation 8.3
|
11.8 Minutes
Standard Deviation 11.6
|
|
Fluoroscopy Time
Fluoroscopy Time to Mapping
|
15.5 Minutes
Standard Deviation 12.6
|
13.8 Minutes
Standard Deviation 11.1
|
|
Fluoroscopy Time
Fluoroscopy Time to Ablation and Verification
|
36.9 Minutes
Standard Deviation 10.9
|
41.5 Minutes
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)Population: Per-protocol population with available outcome data
Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
Outcome measures
| Measure |
Targeted CFAE Ablation
n=38 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=38 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target
|
23.3 Milliseconds
Standard Deviation 33.3
|
25.4 Milliseconds
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)Population: Per-protocol population with available outcome data
Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.
Outcome measures
| Measure |
Targeted CFAE Ablation
n=39 Participants
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=38 Participants
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Incidence of Atrial Fibrillation (AF) Termination/Regularization
|
11 participants
|
14 participants
|
Adverse Events
Targeted CFAE Ablation
Serious events: 15 serious events
Other events: 29 other events
Deaths: 0 deaths
Generalized CFAE Ablation
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Targeted CFAE Ablation
n=42 participants at risk
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=41 participants at risk
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 2 • 12 months post procedure follow up.
|
|
Cardiac disorders
Atrial Flutter
|
4.8%
2/42 • Number of events 5 • 12 months post procedure follow up.
|
4.9%
2/41 • Number of events 2 • 12 months post procedure follow up.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Coronary Artery Disease
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Heart Block
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pacemaker
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pericardial Effusion
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Sinus Node Disease
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Sinus Node Injury
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Tachy-Brady Syndrome
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Abdominal Pain
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Chest Discomfort
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Pruritus
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Infections and infestations
Parasite
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Nervous system disorders
Vocal Chord Paralysis
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
Other adverse events
| Measure |
Targeted CFAE Ablation
n=42 participants at risk
Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
|
Generalized CFAE Ablation
n=41 participants at risk
Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) \> 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Atrial Fibrillation
|
4.8%
2/42 • Number of events 5 • 12 months post procedure follow up.
|
19.5%
8/41 • Number of events 9 • 12 months post procedure follow up.
|
|
Cardiac disorders
Atrial Flutter
|
14.3%
6/42 • Number of events 6 • 12 months post procedure follow up.
|
17.1%
7/41 • Number of events 7 • 12 months post procedure follow up.
|
|
Cardiac disorders
Bradycardia
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Cardioversion
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Chest Discomfort
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Cardiac disorders
Coronary Artery Disease
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Medication Reaction
|
2.4%
1/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Mild Blunting
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Palpitations
|
7.1%
3/42 • Number of events 3 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pericardial Effusion
|
9.5%
4/42 • Number of events 4 • 12 months post procedure follow up.
|
7.3%
3/41 • Number of events 3 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pericardial Separation
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/42 • 12 months post procedure follow up.
|
4.9%
2/41 • Number of events 3 • 12 months post procedure follow up.
|
|
Cardiac disorders
Tachycardia NEC
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Eye disorders
Cataract Surgery
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Eye disorders
Eye Pain
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Eye disorders
Visual Disturbance or Impairment
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Gastrointestinal disorders
Rectal Bleed
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Dermatitis
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Fatigue
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Fluid Overload
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Hematoma
|
7.1%
3/42 • Number of events 5 • 12 months post procedure follow up.
|
7.3%
3/41 • Number of events 3 • 12 months post procedure follow up.
|
|
General disorders
Localized Edema
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Low Potassium
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Medication Reaction
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Pedial Edema
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Post Procedural Elevated Blood Sugar
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Pyrexia
|
11.9%
5/42 • Number of events 5 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
General disorders
Rash
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
General disorders
Wound Complication
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Immune system disorders
Shingles
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Infections and infestations
Dysuria
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Anesthesia Complications
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Glossodynia
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Groin Pain
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/42 • 12 months post procedure follow up.
|
19.5%
8/41 • Number of events 8 • 12 months post procedure follow up.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
2.4%
1/42 • Number of events 2 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Musculoskeletal and connective tissue disorders
Ruptured Tendon
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Nervous system disorders
Headaches
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
7.3%
3/41 • Number of events 3 • 12 months post procedure follow up.
|
|
Nervous system disorders
Trouble Concentrating
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Nervous system disorders
Vasovagal Response
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Psychiatric disorders
Suicidal
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Renal and urinary disorders
Increased Urine Output
|
2.4%
1/42 • Number of events 1 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 3 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.0%
8/42 • Number of events 8 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
0.00%
0/41 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Phrenic Nerve Damage
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/42 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Metabolism and nutrition disorders
Hypertension
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
2.4%
1/41 • Number of events 1 • 12 months post procedure follow up.
|
|
Vascular disorders
Hypotension
|
4.8%
2/42 • Number of events 2 • 12 months post procedure follow up.
|
12.2%
5/41 • Number of events 5 • 12 months post procedure follow up.
|
Additional Information
Ellen Harris, Sr. Clinical Research Associate, Clinical Operations
Biosense Webster EMEA
Phone: (800) 729-9010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is allowed to publish but must submit draft pubs to Biosense Webster, Inc. at least 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER