Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation (POWDER-AF2)
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ClinicalTrials.gov Identifier: NCT03437356 |
Recruitment Status :
Completed
First Posted : February 19, 2018
Last Update Posted : July 11, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation | Other: Pulmonary vein isolation using CLOSE protocol Drug: Antiarrhythmic drug therapy (ADT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 26, 2018 |
Actual Primary Completion Date : | May 30, 2022 |
Actual Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
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Active Comparator: ADT ON Group
'CLOSE'-guided PVI with continuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation.
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Other: Pulmonary vein isolation using CLOSE protocol
'CLOSE' protocol: Ablation index > 400 at the posterior wall (reduce to 300 if esophagus temperature rise), ablation index > 550 at the anterior wall, and inter-lesion distance < 6.0mm Drug: Antiarrhythmic drug therapy (ADT) During the first 3 months after PVI, patients continue oral anticoagulants and antiarrhythmic drug therapy (ADT). ADT is a continuation (or restart) of previously ineffective Class IC and III ADT. At the time of discharge, dosage is optimized according to the 2016 ESC guidelines on AF management. Preferred dosages: Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD) Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or <70 kg Sotalol: Sotalex or Sotalol EG 80mg b.i.d., Except 80mg t.i.d. if men < 70 years, Cr <1.5mg/dl, >70kg, except 80 mg OD if female >70 years or Cr >1.2mg/dl In case of amiodarone intake before PVI, amiodarone is switched to sotalol or class IC ADT. |
Active Comparator: ADT OFF Group
'CLOSE' guided PVI with discontinuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation
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Other: Pulmonary vein isolation using CLOSE protocol
'CLOSE' protocol: Ablation index > 400 at the posterior wall (reduce to 300 if esophagus temperature rise), ablation index > 550 at the anterior wall, and inter-lesion distance < 6.0mm |
- Any documented AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence [ Time Frame: From 3 to 12 months after PVI ]Recurrence will be considered as AF/AT/AF lasting >30 seconds, as measured by 1-day Holter monitoring at 6 month after PVI, 7-day Holter (screening for AF between 48 hours and 7 days) at 12 months after PVI, and by any standard of care or unscheduled arrhythmia monitoring documentation throughout the follow-up (ie. from 3 to 12 months after PVI).
- AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence in early persistent AF [ Time Frame: From 3 to 12 months after PVI ]Incidence of recurrence of early persistent AF
- Repeat ablation [ Time Frame: From 3 to 12 months after PVI ]Incidence of repeat ablation
- Unscheduled health care visits and hospitalizations [ Time Frame: From 3 to 12 months after PVI ]Incidence of unscheduled health care visits and/or hospitalizations
- ADT-related adverse events [ Time Frame: From 3 to 12 months after PVI ]Adverse events related to continuation of ADT in the ON group
- Ablation-related adverse events [ Time Frame: From 0 to 12 months after ablation ]Adverse events related to ablation in both groups
- Quality of life assessment (SF-36) [ Time Frame: At Enrollment, and at 3 months, 6 months, and 12 months after ablation ]At each scheduled visit, the patients will fill the SF-36 questionnaire for the assessment of Quality of life before and after ablation in both groups. SF-36 individual scores (0-100) will be converted into z-scores as standardized combined scores (mean 50, standard deviation 10) for US population (Ware et al.)
- AF symptom scores [ Time Frame: At Enrollment, and at 3 months, 6 months, and 12 months after ablation ]At each scheduled visit, the patients will fill AF checklist: 16 questions of AF severity (score = minimum 16, maximum 48) and 16 questions of AF frequency (score = minimum 16, maximum 64) for qualitative assessment of AF symptoms before and after ablation in both groups.
- Predictors of recurrence [ Time Frame: At baseline ]Any conventional clinical characteristics acquired at baseline that could predict recurrence of AF
- Outcome after repeat ablation [ Time Frame: From 3 to 12 months after first PVI ]Incidence of AF recurrence after multiple ablation procedures (if applicable)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode ≥7 days (ESC 2016 guidelines).
- Before PVI, there was at least one episode of persistent AF in the last year.
- Signed Patient Informed Consent Form.
- Age 18 years or older.
- Able and willing to comply with all follow-up testing and requirements.
Exclusion Criteria:
- Patients not willing or not suited to take any class IC or III ADT.
- Any prior AF episode ≥12 months, or any recurrence of AF <3 days after cardioversion.
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Presence of structural heart disease on echo criteria:
severe valvular heart disease; LA diameter >50mm; LV ejection fraction <35% (except if suspected tachycardiomyopathy); septal diameter >15mm
- BMI >35
- Recent (<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
- Active illness or systemic infection or sepsis
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Awaiting cardiac transplantation or other cardiac surgery
- Documented left atrial thrombus or atrial myxoma on imaging
- History of blood clotting or bleeding abnormalities
- Enrollment in any other study evaluating another device or drug
- Women with childbearing potential
- Life expectancy less than 12 months
- Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437356
Austria | |
Medical University of Graz | |
Graz, Austria | |
Belgium | |
Onze-Lieve-Vrouwziekenhuis Aalst | |
Aalst, Belgium | |
ZNA Middelheim | |
Antwerpen, Belgium | |
AZ Sint-Jan Hospital | |
Bruges, Belgium, 8000 | |
Ziekenhuis Oost-Limburg | |
Genk, Belgium | |
Jessa Ziekenhuis Hasselt | |
Hasselt, Belgium | |
Denmark | |
Gentofte Hospital | |
Gentofte, Denmark | |
Spain | |
Hospital Universitari Germans Trias | |
Barcelona, Spain | |
Switzerland | |
Luzerner Kantonsspital | |
Luzern, Switzerland |
Principal Investigator: | Mattias Duytschaever, MD, PhD | A Sint -Jan Bruges |
Responsible Party: | Prof. Dr. Mattias Duytschaever, Prof. Dr., AZ Sint-Jan AV |
ClinicalTrials.gov Identifier: | NCT03437356 |
Other Study ID Numbers: |
8049201834825 |
First Posted: | February 19, 2018 Key Record Dates |
Last Update Posted: | July 11, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
persistent atrial fibrillation pulmonary vein isolation antiarrhythmic drug therapy |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Anti-Arrhythmia Agents |