Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT03437356
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation
Sponsor:
AZ Sint-Jan AV
Organization:
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 \>37ml/m2, 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 (1:1), 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 continued/restarted 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 ATA's 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 0.05 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 \>37ml/m2, 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 (1:1), 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 continued/restarted 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 ATA's 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 0.05 up to 200 subjects need be enrolled in this study (20 per center)
Study Oversight
Has Oversight DMC:
True
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?: