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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 : Recruiting
First Posted : February 19, 2018
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Pulmonary vein isolation using CLOSE protocol Drug: Antiarrhythmic drug therapy (ADT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. Repeat ablation [ Time Frame: From 3 to 12 months after PVI ]
    Incidence of repeat ablation

  3. Unscheduled health care visits and hospitalizations [ Time Frame: From 3 to 12 months after PVI ]
    Incidence of unscheduled health care visits and/or hospitalizations

  4. ADT-related adverse events [ Time Frame: From 3 to 12 months after PVI ]
    Adverse events related to continuation of ADT in the ON group

  5. Ablation-related adverse events [ Time Frame: From 0 to 12 months after ablation ]
    Adverse events related to ablation in both groups

  6. 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.)

  7. 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.

  8. Predictors of recurrence [ Time Frame: At baseline ]
    Any conventional clinical characteristics acquired at baseline that could predict recurrence of AF

  9. Outcome after repeat ablation [ Time Frame: From 3 to 12 months after first PVI ]
    Incidence of AF recurrence after multiple ablation procedures (if applicable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Before PVI, there was at least one episode of persistent AF in the last year.
  3. Signed Patient Informed Consent Form.
  4. Age 18 years or older.
  5. Able and willing to comply with all follow-up testing and requirements.

Exclusion Criteria:

  1. Patients not willing or not suited to take any class IC or III ADT.
  2. Any prior AF episode ≥12 months, or any recurrence of AF <3 days after cardioversion.
  3. 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

  4. BMI >35
  5. Recent (<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
  6. Active illness or systemic infection or sepsis
  7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  8. Awaiting cardiac transplantation or other cardiac surgery
  9. Documented left atrial thrombus or atrial myxoma on imaging
  10. History of blood clotting or bleeding abnormalities
  11. Enrollment in any other study evaluating another device or drug
  12. Women with childbearing potential
  13. Life expectancy less than 12 months
  14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)

Information from the National Library of Medicine

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


Contacts
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Contact: Mattias Duytschaever, MD, PhD 003250452652 Mattias.Duytschaever@azsintjan.be
Contact: Milad El Haddad, PhD 00358449695025 milad.elhaddad@emdt.eu

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria
Contact: Bernadette Mastnak       bernadette.mastnak@medunigraz.at   
Principal Investigator: Graz Scherr, MD         
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst Recruiting
Aalst, Belgium
Contact: Kathy De Knijf       Kathy.De.Knijf@olvz-aalst.be   
Principal Investigator: Tom De Potter, MD         
ZNA Middelheim Recruiting
Antwerpen, Belgium
Contact: Michael Wolf, MD       michael.wolf@telenet.be   
Principal Investigator: Michael Wolf, MD         
AZ Sint-Jan Hospital Recruiting
Bruges, Belgium, 8000
Contact: Kelly DeJaegher       Kelly.DeJaegher@azsintjan.be   
Contact: Katrien Derycker       Katrien.Derycker@azsintjan.be   
Principal Investigator: Mattias Duytschaever, MD         
Sub-Investigator: Sebastien knecht, MD         
Sub-Investigator: Tavernier Rene, MD         
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium
Contact: Evi Theunissen       Evi.Theunissen@zol.be   
Principal Investigator: Maximo Rivero, MD         
Jessa Ziekenhuis Hasselt Recruiting
Hasselt, Belgium
Contact: Arne Janssen       Arne.Janssen@jessazh.be   
Principal Investigator: Johan Vijgen, MD         
Denmark
Gentofte Hospital Recruiting
Gentofte, Denmark
Contact: Julie Laage-Petersen       Julie.Laage-Petersen@regionh.dk   
Principal Investigator: Arne Johannessen, MD         
France
Centre Hospitalier Universitaire de Nancy Not yet recruiting
Nancy, France
Contact: Véronique Midenet       v.midenet@chru-nancy.fr   
Contact: Christelle Simonot       c.simonot@chru-nancy.fr   
Principal Investigator: Christian De Chillou, MD         
Assistance Publique - Hôpitaux de Paris Not yet recruiting
Paris, France
Contact: Cecile Naudin       Cecile.naudin@clinique-a-pare.fr   
Principal Investigator: Alexander Zhao, MD         
Germany
Alfried Krupp Hospital Not yet recruiting
Essen, Germany
Contact: Kars Neven, MD       kars.neven@krupp-krankenhaus.de   
Principal Investigator: Kars Neven, MD         
Italy
Policlinic Casilino Division of Cardiology Not yet recruiting
Rome, Italy
Contact: Ermenegildo De Ruvo, MD       bioetica.polcas@eurosanita.it   
Principal Investigator: Ermenegildo De Ruvo, MD         
Spain
Hospital Universitari Germans Trias Not yet recruiting
Barcelona, Spain
Contact: Asier Molinero       electrofisiologia.germanstrias@gencat.cat   
Principal Investigator: Felipe Bisbal, MD         
Switzerland
Luzerner Kantonsspital Recruiting
Luzern, Switzerland
Contact: Brigitta Mehmann       brigitta.mehmann@luks.ch   
Principal Investigator: Richard Kobza, MD         
Sub-Investigator: Benjamin Berte, MD         
Sponsors and Collaborators
AZ Sint-Jan AV
Biosense Webster, Inc.
Investigators
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Principal Investigator: Mattias Duytschaever, MD, PhD A Sint -Jan Bruges

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Responsible Party: Prof. Dr. Mattias Duytschaever, Prof. Dr., AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03437356     History of Changes
Other Study ID Numbers: 8049201834825
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV:
persistent atrial fibrillation
pulmonary vein isolation
antiarrhythmic drug therapy
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents