Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03437356
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2018-02-05
Brief Title:
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation
Sponsor:
AZ Sint-Jan AV
Organization:
AZ Sint-Jan AV
Study Overview
Official Title:
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Persistent Atrial Fibrillation a Prospective Multi-centre Randomized Controlled Clinical Study
Status:
COMPLETED
Status Verified Date:
2022-07
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:
POWDER-AF2
Brief Summary:
In the POWDER 1 study paroxysmal atrial fibrillation AF patients undergoing conventional contact force CF-guided PVI were investigated Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy ADT or stopping ADT at the end of the blanking period This trial showed an added value of ADT after ablation in support of hybrid rhythm control as an alternative treatment strategy for AF in some patients
In the POWDER 2 trial an analogue study in persistent AF patients will be performed All patients will undergo ablation index AI- and IL distance ILD-guided PVI just like in VISTAX trial and continue previously ineffective ADT during the blanking period PVI only was chosen as the ablation strategy according to the STAR AF trial findings
In the POWDER 2 trial an analogue study in persistent AF patients will be performed All patients will undergo ablation index AI- and IL distance ILD-guided PVI just like in VISTAX trial and continue previously ineffective ADT during the blanking period PVI only was chosen as the ablation strategy according to the STAR AF trial findings
Detailed Description:
Background In real-life ADT is often continued after catheter ablation for persistent AF No study investigated whether ADT continued beyond the blanking period reduces recurrence after a first ablation for persistent AF
Purpose The aim of this trial is to investigate whether continued ADT ADT ON reduces recurrence of atrial tachyarrhythmia ATA in the first year after contact-force guided PVI for persistent AF
Hypothesis Continued use of ADT beyond the blanking period reduces recurrence of ATA in the first year after PVI
Eligibility Subjects that are planned for catheter ablation for persistent AF
Inclusion Symptomatic persistent AF resistant to ongoing or prior ADT failed ADT Persistent AF is defined as the presence of any prior AF episode 7 days
Exclusion Any prior AF episode 12 months any recurrence of AF 3 days after cardioversion
Echo criteria advanced valvular heart disease left atrium LA volume 37mlm2 left ventricle LV ejection fraction 35 except if suspected tachycardiomyopathy septal diameter 15mm Life expectancy 1 year BMI 35
Trial design This is a prospective multi-center randomized 11 open label blinded endpoint study PROBE Eligible subjects who sign the study informed consent form at the time of procedural planning will be randomized into one of two study arms In the ADT off arm ADT OFF ADT will be stopped at 3 months after the first procedure In the ADT ON arm ADT will be continued at 3 months until 1 year follow up FU
First ablation and blanking In both arms catheter ablation will consist of CLOSE-guided PVI only abl index and interlesion distance High-density voltage mapping will be performed during sinus rhythm After ablation ADT is continuedrestarted during the 3-month blanking period except for amiodarone During the blanking period cardioversions are allowed At the 3-month visit all patients will be cardioverted if ATA is present
Repeat ablation strategy In case of recurrence of ATAs after 3 months a repeat ablation is recommended Depending on the reconnection status of the pulmonary veins PV repeat ablation will consist of either PVI only or a patient-tailored ablation approach antral isolation superior vena cava SVC isolation isolation of low voltage linear lesions Patients stay on the ADT ON or ADT OFF arm
Primary Endpoint Any documented ATA atrial fibrillation AF atrial tachycardia AT atrial flutter AFL lasting 30s from 3 months through 12 month follow-up after the first procedure
Secondary Endpoints
ATA recurrence in patients with early peristent AF defined as AF 3 months Incidence of repeat ablation Unscheduled visits and hospitalisation ADT or ablation related adverse events QOL and symptoms Outcome after repeat ablation
Sample size In the ADT OFF group ATA recurrence after a first PVI is expected to be 50 ADT are expected to reduce ATA recurrence to 30 Given power of 80 and α of 005 up to 200 subjects need be enrolled in this study 20 per center
Purpose The aim of this trial is to investigate whether continued ADT ADT ON reduces recurrence of atrial tachyarrhythmia ATA in the first year after contact-force guided PVI for persistent AF
Hypothesis Continued use of ADT beyond the blanking period reduces recurrence of ATA in the first year after PVI
Eligibility Subjects that are planned for catheter ablation for persistent AF
Inclusion Symptomatic persistent AF resistant to ongoing or prior ADT failed ADT Persistent AF is defined as the presence of any prior AF episode 7 days
Exclusion Any prior AF episode 12 months any recurrence of AF 3 days after cardioversion
Echo criteria advanced valvular heart disease left atrium LA volume 37mlm2 left ventricle LV ejection fraction 35 except if suspected tachycardiomyopathy septal diameter 15mm Life expectancy 1 year BMI 35
Trial design This is a prospective multi-center randomized 11 open label blinded endpoint study PROBE Eligible subjects who sign the study informed consent form at the time of procedural planning will be randomized into one of two study arms In the ADT off arm ADT OFF ADT will be stopped at 3 months after the first procedure In the ADT ON arm ADT will be continued at 3 months until 1 year follow up FU
First ablation and blanking In both arms catheter ablation will consist of CLOSE-guided PVI only abl index and interlesion distance High-density voltage mapping will be performed during sinus rhythm After ablation ADT is continuedrestarted during the 3-month blanking period except for amiodarone During the blanking period cardioversions are allowed At the 3-month visit all patients will be cardioverted if ATA is present
Repeat ablation strategy In case of recurrence of ATAs after 3 months a repeat ablation is recommended Depending on the reconnection status of the pulmonary veins PV repeat ablation will consist of either PVI only or a patient-tailored ablation approach antral isolation superior vena cava SVC isolation isolation of low voltage linear lesions Patients stay on the ADT ON or ADT OFF arm
Primary Endpoint Any documented ATA atrial fibrillation AF atrial tachycardia AT atrial flutter AFL lasting 30s from 3 months through 12 month follow-up after the first procedure
Secondary Endpoints
ATA recurrence in patients with early peristent AF defined as AF 3 months Incidence of repeat ablation Unscheduled visits and hospitalisation ADT or ablation related adverse events QOL and symptoms Outcome after repeat ablation
Sample size In the ADT OFF group ATA recurrence after a first PVI is expected to be 50 ADT are expected to reduce ATA recurrence to 30 Given power of 80 and α of 005 up to 200 subjects need be enrolled in this study 20 per center
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