Trial Outcomes & Findings for Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation (NCT NCT01558635)
NCT ID: NCT01558635
Last Updated: 2019-07-30
Results Overview
The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
12 months
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Treated
|
17
|
|
Overall Study
Discharge /1 Month Post-procedure
|
15
|
|
Overall Study
3 Months Post-procedure
|
14
|
|
Overall Study
6 Months Post-procedure
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Subject received other treatment
|
1
|
|
Overall Study
Reveal XT was explanted
|
1
|
Baseline Characteristics
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=17 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class I
|
3 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class II
|
11 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class III
|
3 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class IV
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: There were 11 subjects with data at 12 months, including antiarrhythmic drug, ablation, and cardioversion data. However, only six subjects had the AF burden data required for the primary efficacy endpoint.
The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=6 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All subjects treated with the Cardioblate Cryoflex Surgical Ablation System.
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=17 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Cardiac Death
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Non-Cardiac Death
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Stroke
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Transient Ischemic Attack
|
1 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Pulmonary Embolism
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Peripheral Arterial Embolism
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Myocardial Infarction
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Mediastinitis
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Esophageal Injury
|
0 Participants
|
—
|
—
|
|
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Cardiac Injury related to the use of Ablation
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: All subjects who underwent ablation therapy and who had data from the Reveal XT Insertable Cardiac Monitor
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=6 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 MonthsOutcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=8 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsOutcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=4 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6 and 12 MonthsAF burden is defined as percentage of time the patient is in AF during 24 hours.
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=8 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
n=5 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
n=6 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months
|
3.0 percentage of AF burden
Standard Deviation 6.7
|
1.3 percentage of AF burden
Standard Deviation 2.8
|
2.4 percentage of AF burden
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 6 and 12 monthsThe 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale.
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=16 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
n=14 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
n=10 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Physical Component Summary (PCS)
|
38.0 units on a scale
Standard Deviation 10.4
|
46.7 units on a scale
Standard Deviation 10.0
|
43.4 units on a scale
Standard Deviation 9.4
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Mental Component Summary (MCS)
|
47.2 units on a scale
Standard Deviation 10.3
|
52.7 units on a scale
Standard Deviation 12.0
|
56.1 units on a scale
Standard Deviation 9.7
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Physical Functioning
|
36.6 units on a scale
Standard Deviation 12.8
|
46.6 units on a scale
Standard Deviation 10.6
|
42.7 units on a scale
Standard Deviation 11.6
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Role Physical
|
37.3 units on a scale
Standard Deviation 13.2
|
45.3 units on a scale
Standard Deviation 10.0
|
43.4 units on a scale
Standard Deviation 11.9
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Bodily Pain
|
45.3 units on a scale
Standard Deviation 13.0
|
50.9 units on a scale
Standard Deviation 11.7
|
52.3 units on a scale
Standard Deviation 7.2
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
General Health
|
36.9 units on a scale
Standard Deviation 10.8
|
48.4 units on a scale
Standard Deviation 8.7
|
46.7 units on a scale
Standard Deviation 9.3
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Vitality
|
49.6 units on a scale
Standard Deviation 12.3
|
53.5 units on a scale
Standard Deviation 11.0
|
54.8 units on a scale
Standard Deviation 6.8
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Social Functioning
|
43.9 units on a scale
Standard Deviation 13.0
|
50.8 units on a scale
Standard Deviation 9.5
|
49.5 units on a scale
Standard Deviation 9.6
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Role Emotional
|
39.0 units on a scale
Standard Deviation 14.5
|
47.3 units on a scale
Standard Deviation 12.4
|
51.0 units on a scale
Standard Deviation 7.7
|
|
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
Mental Health
|
46.6 units on a scale
Standard Deviation 10.1
|
53.2 units on a scale
Standard Deviation 11.7
|
54.8 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: 12 monthsThe composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Outcome measures
| Measure |
Cardioblate CryoFlex Surgical Ablation
n=17 Participants
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 6 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
AF Burden in Treated Subjects After 12 Months Follow-Up
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|---|---|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Cardiac Death
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Non-Cardiac Death
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Stroke
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Transient Ischemic Attack (TIA)
|
1 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Pulmonary Embolism
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Peripheral Arterial Embolism
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Mediastinitis
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Esophageal Injury
|
0 Participants
|
—
|
—
|
|
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
Cardiac Injury related to the use of Ablation
|
0 Participants
|
—
|
—
|
Adverse Events
Cardioblate CryoFlex Surgical Ablation Group With 12 Months of
Serious events: 9 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cardioblate CryoFlex Surgical Ablation Group With 12 Months of
n=17 participants at risk
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|
|
Nervous system disorders
Transient Ischemic Attack
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 2 • 12 Months
|
|
Cardiac disorders
Ventriculr Block, Second Degree
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
23.5%
4/17 • Number of events 4 • 12 Months
|
|
Vascular disorders
Haemodynamic Instability
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Renal and urinary disorders
Renal Failure
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.8%
2/17 • Number of events 2 • 12 Months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Infections and infestations
Pulmonary Sepsis
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Ventricular Dysfunction
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Cardiac Failure
|
11.8%
2/17 • Number of events 2 • 12 Months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
11.8%
2/17 • Number of events 2 • 12 Months
|
|
Cardiac disorders
Bundle Branch Block, Right
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Infections and infestations
Haematoma Infection
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Intracardiac Thrombus
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Atrioventricular Block, Complete
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Pericardial Effusion
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Injury, poisoning and procedural complications
Postoperative Renal Failure
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
5.9%
1/17 • Number of events 1 • 12 Months
|
Other adverse events
| Measure |
Cardioblate CryoFlex Surgical Ablation Group With 12 Months of
n=17 participants at risk
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
|
|---|---|
|
Vascular disorders
Arterial Hypotension
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Psychiatric disorders
Transient Psychosis
|
11.8%
2/17 • Number of events 2 • 12 Months
|
|
Metabolism and nutrition disorders
Hyponatriaemia
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Injury, poisoning and procedural complications
Postoperative Delirium
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Injury, poisoning and procedural complications
Postoperative Anemia
|
5.9%
1/17 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Pericardial Effusion
|
5.9%
1/17 • Number of events 1 • 12 Months
|
Additional Information
Ber Kleijnen, Sr Clinical Research Manager
Medtronic, Bakken Research Center, Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands
Phone: +31653227763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60