Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383975
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-16
Brief Title:
VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF
Sponsor:
Sebastien Knecht
Organization:
AZ Sint-Jan AV
Study Overview
Official Title:
Comparison Between VEin of MArshall Ethanol Infusion Versus Extended Pulmonary Vein PULSEd Field Ablation After Failed Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
VEMAPULSE
Brief Summary:
The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation irregular and often very rapid heart rhythm An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat In this trial researchers will compare a new technique which uses tiny electric shocks to make the scars to the standard technique which uses heat
The main question the trial aims to answer is
Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure
Participants will
Undergo an ablation with either the new or the standard technique
Visit the hospital 1 3 6 9 and 12 months after the procedure for a check-up
Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6 9 and 12 month visit
Record their heart rhythm at home every week
Complete a questionnaire 3 6 9 and 12 months after the procedure
The main question the trial aims to answer is
Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure
Participants will
Undergo an ablation with either the new or the standard technique
Visit the hospital 1 3 6 9 and 12 months after the procedure for a check-up
Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6 9 and 12 month visit
Record their heart rhythm at home every week
Complete a questionnaire 3 6 9 and 12 months after the procedure
Detailed Description:
Background
Pulmonary vein isolation PVI remains the cornerstone of catheter ablation for the treatment of atrial fibrillation AF However in patients with persistent AF recurrence occurs in 20 to 50 of the patients These patients often need additional ablation beyond PVI in the index procedure or in a redo procedure During redo procedures optimal management of AF has not been validated yet Different strategies are used but without strong scientific background and without uniformity
In the case of PV reconnection PV re-isolation alone seems to be the gold standard in healthy atria but with moderate success in patients with dilated left atrium or scar zones
Different recent studies show a potential impact of posterior wall isolation however with discordant results This could be in part related to low rate of durable posterior wall isolation and also due to potential risk of esophageal fistula limiting the use of RF ablation at the posterior wall The use of pulsed field energy could improve lesion durability and avoid any risk of fistula
On the other hand ethanol infusion in the vein of Marshal has also been shown to improve the success rate of persistent AF ablation but requires significant experience and may be time-consuming
Rationale
Currently there are no clear ablation endpoints in the case of AF recurrence post PVI Especially for patients with persistent AF since substrate ablation beyond PVI does not seem to improve the success rate during a first procedure However this could be related to inappropriate patient selection Indeed PVI-resistant patients present those with worst prognosis with respect to AF recurrence Additionally when durable PVI is observed following recurrence in patients with persistent AF case ablation beyond PVI seems reasonable and necessary
The aim of this trial is to compare two strategies with clear endpoints to avoid potential bias The gold standard PVI is also respected in both groups In one group PFA re-isolation of PVs and of the posterior wall has the advantage of a clear straight forward approach with short-lasting procedures and which does not require high level technical skills
In the second group radiofrequency guided PV re-isolation will be performed in combination with mitral aided by vein of Marshall ethanol infusion and dome lines until bidirectional block A Vein of Marshall is present in 90 of the patients and strongly facilitates block at the mitral line almost 100 while a dome transection reduces the risk of further left atrial tachyarrhythmia
Hypothesis
The hypothesis of this study is that the efficacy of a straightforward strategy of PV re-isolation if necessary and additional posterior wall isolation using the PFA FARAPULSETM catheter is comparable to that of a more complex and time consuming RF strategy aiming at vein of Marshall ethanol infusion and linear lesions at the roof and at the mitral line
Design
This is a prospective randomized 11 open label blinded endpoint study PROBE Eligible subjects who sign the study informed consent form with persistent AF will be randomized into one of two study arms In the pulsed field ablation PFA arm patients will be treated using the FARAPULSETM catheter aiming at pulmonary vein PV re-isolation if necessary and isolation of the posterior wall In the radiofrequency RF group patients will receive ethanol infusion in the vein of Marshall followed by re-isolation of the PV if necessary dome and mitral lines with aim at bidirectional block
Pulmonary vein isolation PVI remains the cornerstone of catheter ablation for the treatment of atrial fibrillation AF However in patients with persistent AF recurrence occurs in 20 to 50 of the patients These patients often need additional ablation beyond PVI in the index procedure or in a redo procedure During redo procedures optimal management of AF has not been validated yet Different strategies are used but without strong scientific background and without uniformity
In the case of PV reconnection PV re-isolation alone seems to be the gold standard in healthy atria but with moderate success in patients with dilated left atrium or scar zones
Different recent studies show a potential impact of posterior wall isolation however with discordant results This could be in part related to low rate of durable posterior wall isolation and also due to potential risk of esophageal fistula limiting the use of RF ablation at the posterior wall The use of pulsed field energy could improve lesion durability and avoid any risk of fistula
On the other hand ethanol infusion in the vein of Marshal has also been shown to improve the success rate of persistent AF ablation but requires significant experience and may be time-consuming
Rationale
Currently there are no clear ablation endpoints in the case of AF recurrence post PVI Especially for patients with persistent AF since substrate ablation beyond PVI does not seem to improve the success rate during a first procedure However this could be related to inappropriate patient selection Indeed PVI-resistant patients present those with worst prognosis with respect to AF recurrence Additionally when durable PVI is observed following recurrence in patients with persistent AF case ablation beyond PVI seems reasonable and necessary
The aim of this trial is to compare two strategies with clear endpoints to avoid potential bias The gold standard PVI is also respected in both groups In one group PFA re-isolation of PVs and of the posterior wall has the advantage of a clear straight forward approach with short-lasting procedures and which does not require high level technical skills
In the second group radiofrequency guided PV re-isolation will be performed in combination with mitral aided by vein of Marshall ethanol infusion and dome lines until bidirectional block A Vein of Marshall is present in 90 of the patients and strongly facilitates block at the mitral line almost 100 while a dome transection reduces the risk of further left atrial tachyarrhythmia
Hypothesis
The hypothesis of this study is that the efficacy of a straightforward strategy of PV re-isolation if necessary and additional posterior wall isolation using the PFA FARAPULSETM catheter is comparable to that of a more complex and time consuming RF strategy aiming at vein of Marshall ethanol infusion and linear lesions at the roof and at the mitral line
Design
This is a prospective randomized 11 open label blinded endpoint study PROBE Eligible subjects who sign the study informed consent form with persistent AF will be randomized into one of two study arms In the pulsed field ablation PFA arm patients will be treated using the FARAPULSETM catheter aiming at pulmonary vein PV re-isolation if necessary and isolation of the posterior wall In the radiofrequency RF group patients will receive ethanol infusion in the vein of Marshall followed by re-isolation of the PV if necessary dome and mitral lines with aim at bidirectional block
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