Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03811639
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-12-29
Brief Title:
Changes in Cardiac Autonomic Nervous System Following Atrial Fibrillation Ablation
Sponsor:
Centre of Postgraduate Medical Education
Organization:
Centre of Postgraduate Medical Education
Study Overview
Official Title:
ABLation-induced Changes in Cardiac Autonomic Nervous System in Patients With Atrial Fibrillation Radiofrequency Versus Cryoballoon Techniques The ABLANSAF Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABLANSAF
Brief Summary:
Aim To compare changes in cardiac autonomic tone caused by radio-frequency versus cryoballoon ablation and to assess their value in predicting the outcome
Study group In this prospective randomized study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using radio-frequency RF or cryoballoon CB technique will be recruited Patients will undergo several ECG and autonomic tests before and after the procedure The follow-up will last one year
Measurements
1 Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed The SR and P wave duration as well as the difference in SR and P wave duration before and after ablation will be analyzed
2 A 24-hour Holter ECG will be performed at baseline 1-2 days before ablation and 7-day Holter ECG will be performed 3 6 and 12 months after the procedure Minimal maximal and mean heart rate HR as well as HRV parameters will be analyzed The differences in these variables between baseline and post-ablation Holter ECG recordings will be analyzed
3 Autonomic parameters HR HRV parameters and baroreceptor reflex sensitivity as well as hemodynamic parameters stroke volume SV cardiac output CO total peripheral resistance TPR will be also examined before and after orthostatic stress This will be performed using tilt table test and non-invasive measurement of autonomic and hemodynamic parameters before and shortly after 1-3 days the procedure
4 Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3 6 and 12 months after ablation
5 Follow-up will last 12 months Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3 6 and 12 months after the procedure The analyzed outcomes will include symptomatic recurrences of AF hospitalizations due to AF redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring
6 All the above listed parameters and ablation efficacy will be compared between the RF and CB groups
Anticipated results
1 Ablation significantly effects the parameters of cardiac autonomic control
2 These effects are more pronounced in the CB group compared with the RF group
3 Changes in autonomic indices have value in predicting ablation efficacy in both analyzed groups
Study group In this prospective randomized study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using radio-frequency RF or cryoballoon CB technique will be recruited Patients will undergo several ECG and autonomic tests before and after the procedure The follow-up will last one year
Measurements
1 Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed The SR and P wave duration as well as the difference in SR and P wave duration before and after ablation will be analyzed
2 A 24-hour Holter ECG will be performed at baseline 1-2 days before ablation and 7-day Holter ECG will be performed 3 6 and 12 months after the procedure Minimal maximal and mean heart rate HR as well as HRV parameters will be analyzed The differences in these variables between baseline and post-ablation Holter ECG recordings will be analyzed
3 Autonomic parameters HR HRV parameters and baroreceptor reflex sensitivity as well as hemodynamic parameters stroke volume SV cardiac output CO total peripheral resistance TPR will be also examined before and after orthostatic stress This will be performed using tilt table test and non-invasive measurement of autonomic and hemodynamic parameters before and shortly after 1-3 days the procedure
4 Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3 6 and 12 months after ablation
5 Follow-up will last 12 months Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3 6 and 12 months after the procedure The analyzed outcomes will include symptomatic recurrences of AF hospitalizations due to AF redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring
6 All the above listed parameters and ablation efficacy will be compared between the RF and CB groups
Anticipated results
1 Ablation significantly effects the parameters of cardiac autonomic control
2 These effects are more pronounced in the CB group compared with the RF group
3 Changes in autonomic indices have value in predicting ablation efficacy in both analyzed groups
Detailed Description:
ABLation-induced changes in cardiac Autonomic Nervous System in patients with Atrial Fibrillation radiofrequency versus cryoballoon techniques the ABLANSAF study
Introduction The primary goal of ablation for atrial fibrillation AF is pulmonary vein isolation PVI The second mechanism of action of ablation is modification of cardiac autonomic tone by ablation of atrial ganglionated plexi mainly of their parasympathetic component Data in literature concerning this topic is scares A few studies showed that ablation-induced changes in heart rate variability HRV or sinus rate SR predict the outcome However these data are preliminary and have not yet been included into clinical practice Moreover whether these effects depend on the technique used - radio-frequency RF ablation or cryoballoon CB ablation has not yet been examined
Aim To compare the changes in cardiac autonomic tone caused by RF versus CB ablation and to assess their value in predicting the outcome after the procedure
Hypothesis We hypothesised that both techniques cause significant changes in cardiac autonomic innervation however these changes are significantly more pronounced following CB rather than RF ablation
Methods Study group In this prospective randomised study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using RF or CB technique will be recruited Patients will undergo several ECG and autonomic tests before and after the procedure The follow-up will last one year
Ablation The RF and CB ablation will be performed using standard approach A patient will be randomly selected to RF or CB ablation The only parameter influencing randomisation will be the presence of the common trunk of the left PV visualised by computed tomography or rotational angiography which is regarded as relative contraindication to CB because of anatomical difficulties in the positioning of balloon In such cases the decision as to the type of procedure will be left to the discretion of the operator
The CB PVI will be conducted in standard manner Briefly after injection of local anesthetic both femoral veins is punctured One long sheath 85 F Swartz St Jude Saint Paul USA to cross interatrial septum is inserted in the right femoral vein Another two short sheaths were inserted in the left femoral vein for the intracardiac echocardiographic probe 8 or 10 Fr Acunav Acuson Siemens Berlin and diagnostic catheter introduced into the coronary sinus After crossing the septum and introducing guidewire into the left superior pulmonary vein LSPV long sheath is replaced with steerable sheath 14 F Flexcath Medtronic Minneapolis USA and CB 28 mm second generation is introduced into the left atrium Next the Achieve 20 mm diameter mapping catheter Medtronic Milwaukee USA is placed in the LSPV ostium CB inflated and contrast injected to confirm proper occlusion of LSPV When PVI is achieved during first freezing lasting 180 - 240 sec and confirmed by PV potentials PVP disappearance within 60 seconds by recordings from the Achieve catheter no second cryoapplication is performed In case of incomplete occlusion persistence or very late disappearance of PVP suboptimal temperatures achieved less than -36C or very short thawing time CB is repositioned and another cryo-application is delivered Next CB-PVI of the left inferior pulmonary vein LIPV right superior pulmonary vein RSPV and right inferior pulmonary vein RIPV is performed Pacing of the right phrenic nerve is performed during CB of the right veins to avoid phrenic nerve palsy
The RF ablation is performed in a standard manner using 3-D electro-anatomical system CARTO-3 Biosense Webster USA and Smarttouch ablation catheter Two separate transseptal punctures are performed under intracardiac echocardiography guidance After reconstruction of the left atrial geometry using merging of the computed tomography or rotational angiography image with the CARTO map the point-by-point PVI of each vein is performed The ablation index is used to ensure the quality of RF applications The Lasso circular catheter Biosense Webster USA is used to assess PVI and diagnostic catheter placed in the coronary sinus is used for pacing manoeuvres
Measurements
1 Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed The SR and P wave duration as well as the difference in SR and P wave duration before and after ablation will be analysed
2 A 24-hour Holter ECG will be performed at baseline 1-2 days before ablation and 7-day Holter ECG will be performed 3 6 and 12 months after the procedure Minimal maximal and mean heart rate HR as well as time-domain HRV parameters SDNN SDANN pNN50 rMSSD and frequency-domain HRV indices LF HF LFHF will be analysed The differences in these variables between baseline and post-ablation Holter ECG recordings will be analysed
3 Autonomic parameters HR frequency-domain HRV parameters and baro-reflex sensitivity BRS using sequential method as well as hemodynamic parameters stroke volume SV cardiac output CO total peripheral resistance TPR will be also examined before and after orthostatic stress This will be performed using tilt table test 70 degrees and non-invasive measurement of autonomic and hemodynamic parameters cardiac impedance method using the Task Force system before 1-2 days and shortly after 1-3 days the procedure The 5-min ECG recordings will be used to calculate the values of autonomic and haemodynamic parameters Also of these parameters will be computed The values measured before and after ablation before and after tilt testing as well will be compared
4 Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3 6 and 12 months after ablation
5 Follow-up will last 12 months Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3 6 and 12 months after the procedure The analysed outcomes will include symptomatic recurrences of AF hospitalisations due to AF redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring Efficacy of the procedure will be assessed and defined as 1 complete efficacy - no symptoms attributed to AF and no AF on Holter ECG monitoring 2 symptomatic efficacy - no symptoms attributed to AF but AF episodes 30 sec recorded on Holter ECG monitoring 3 partial efficacy - recurrences of symptomatic AF however of lower intensity defined as improvement of at least 1 degree in the EHRA scale and improvement in the AFSS scale and 4 no effects - no change in symptoms compared with the pre-ablation periods
6 All the above listed parameters and ablation efficacy will be compared between the RF and CB groups
Statistical analysis The results will be presented as meanSD normally distributed variables or median values not normally distributed variables The changes between baseline and parameters obtained after ablation as well as before and after tilt testing will be performed using paired two-tailed Student t-test Mann-Whitney or ANOVA tests where appropriate The results obtained in the RF versus CB groups will be compared using unpaired Student t-test The predictive value of examined parameters in identifying responders to ablation will be assessed using the ROC curves and by computing sensitivity specificity positive and negative predictive value Multivariate analysis will be performed to identify parameters independently associated with ablation efficacy A p value 005 will be considered significant
The estimated number of patients sufficient to detect significant difference between the RF and CB groups is 126 based on the assumption that ablation-induced changes in cardiac autonomic parameters will differ between the RF and CB groups by 20 alfa error 005 and beta error 02 Anticipated results
1 Ablation significantly effects the parameters of cardiac autonomic control
2 These effects are more pronounced in the CB group compared with the RF group
3 Changes in autonomic indices have value in predicting ablation efficacy in both analysed groups
Introduction The primary goal of ablation for atrial fibrillation AF is pulmonary vein isolation PVI The second mechanism of action of ablation is modification of cardiac autonomic tone by ablation of atrial ganglionated plexi mainly of their parasympathetic component Data in literature concerning this topic is scares A few studies showed that ablation-induced changes in heart rate variability HRV or sinus rate SR predict the outcome However these data are preliminary and have not yet been included into clinical practice Moreover whether these effects depend on the technique used - radio-frequency RF ablation or cryoballoon CB ablation has not yet been examined
Aim To compare the changes in cardiac autonomic tone caused by RF versus CB ablation and to assess their value in predicting the outcome after the procedure
Hypothesis We hypothesised that both techniques cause significant changes in cardiac autonomic innervation however these changes are significantly more pronounced following CB rather than RF ablation
Methods Study group In this prospective randomised study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using RF or CB technique will be recruited Patients will undergo several ECG and autonomic tests before and after the procedure The follow-up will last one year
Ablation The RF and CB ablation will be performed using standard approach A patient will be randomly selected to RF or CB ablation The only parameter influencing randomisation will be the presence of the common trunk of the left PV visualised by computed tomography or rotational angiography which is regarded as relative contraindication to CB because of anatomical difficulties in the positioning of balloon In such cases the decision as to the type of procedure will be left to the discretion of the operator
The CB PVI will be conducted in standard manner Briefly after injection of local anesthetic both femoral veins is punctured One long sheath 85 F Swartz St Jude Saint Paul USA to cross interatrial septum is inserted in the right femoral vein Another two short sheaths were inserted in the left femoral vein for the intracardiac echocardiographic probe 8 or 10 Fr Acunav Acuson Siemens Berlin and diagnostic catheter introduced into the coronary sinus After crossing the septum and introducing guidewire into the left superior pulmonary vein LSPV long sheath is replaced with steerable sheath 14 F Flexcath Medtronic Minneapolis USA and CB 28 mm second generation is introduced into the left atrium Next the Achieve 20 mm diameter mapping catheter Medtronic Milwaukee USA is placed in the LSPV ostium CB inflated and contrast injected to confirm proper occlusion of LSPV When PVI is achieved during first freezing lasting 180 - 240 sec and confirmed by PV potentials PVP disappearance within 60 seconds by recordings from the Achieve catheter no second cryoapplication is performed In case of incomplete occlusion persistence or very late disappearance of PVP suboptimal temperatures achieved less than -36C or very short thawing time CB is repositioned and another cryo-application is delivered Next CB-PVI of the left inferior pulmonary vein LIPV right superior pulmonary vein RSPV and right inferior pulmonary vein RIPV is performed Pacing of the right phrenic nerve is performed during CB of the right veins to avoid phrenic nerve palsy
The RF ablation is performed in a standard manner using 3-D electro-anatomical system CARTO-3 Biosense Webster USA and Smarttouch ablation catheter Two separate transseptal punctures are performed under intracardiac echocardiography guidance After reconstruction of the left atrial geometry using merging of the computed tomography or rotational angiography image with the CARTO map the point-by-point PVI of each vein is performed The ablation index is used to ensure the quality of RF applications The Lasso circular catheter Biosense Webster USA is used to assess PVI and diagnostic catheter placed in the coronary sinus is used for pacing manoeuvres
Measurements
1 Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed The SR and P wave duration as well as the difference in SR and P wave duration before and after ablation will be analysed
2 A 24-hour Holter ECG will be performed at baseline 1-2 days before ablation and 7-day Holter ECG will be performed 3 6 and 12 months after the procedure Minimal maximal and mean heart rate HR as well as time-domain HRV parameters SDNN SDANN pNN50 rMSSD and frequency-domain HRV indices LF HF LFHF will be analysed The differences in these variables between baseline and post-ablation Holter ECG recordings will be analysed
3 Autonomic parameters HR frequency-domain HRV parameters and baro-reflex sensitivity BRS using sequential method as well as hemodynamic parameters stroke volume SV cardiac output CO total peripheral resistance TPR will be also examined before and after orthostatic stress This will be performed using tilt table test 70 degrees and non-invasive measurement of autonomic and hemodynamic parameters cardiac impedance method using the Task Force system before 1-2 days and shortly after 1-3 days the procedure The 5-min ECG recordings will be used to calculate the values of autonomic and haemodynamic parameters Also of these parameters will be computed The values measured before and after ablation before and after tilt testing as well will be compared
4 Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3 6 and 12 months after ablation
5 Follow-up will last 12 months Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3 6 and 12 months after the procedure The analysed outcomes will include symptomatic recurrences of AF hospitalisations due to AF redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring Efficacy of the procedure will be assessed and defined as 1 complete efficacy - no symptoms attributed to AF and no AF on Holter ECG monitoring 2 symptomatic efficacy - no symptoms attributed to AF but AF episodes 30 sec recorded on Holter ECG monitoring 3 partial efficacy - recurrences of symptomatic AF however of lower intensity defined as improvement of at least 1 degree in the EHRA scale and improvement in the AFSS scale and 4 no effects - no change in symptoms compared with the pre-ablation periods
6 All the above listed parameters and ablation efficacy will be compared between the RF and CB groups
Statistical analysis The results will be presented as meanSD normally distributed variables or median values not normally distributed variables The changes between baseline and parameters obtained after ablation as well as before and after tilt testing will be performed using paired two-tailed Student t-test Mann-Whitney or ANOVA tests where appropriate The results obtained in the RF versus CB groups will be compared using unpaired Student t-test The predictive value of examined parameters in identifying responders to ablation will be assessed using the ROC curves and by computing sensitivity specificity positive and negative predictive value Multivariate analysis will be performed to identify parameters independently associated with ablation efficacy A p value 005 will be considered significant
The estimated number of patients sufficient to detect significant difference between the RF and CB groups is 126 based on the assumption that ablation-induced changes in cardiac autonomic parameters will differ between the RF and CB groups by 20 alfa error 005 and beta error 02 Anticipated results
1 Ablation significantly effects the parameters of cardiac autonomic control
2 These effects are more pronounced in the CB group compared with the RF group
3 Changes in autonomic indices have value in predicting ablation efficacy in both analysed groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None