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Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

NCT03437356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-07-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Mattias Duytschaever, MD, PhD · A Sint -Jan Bruges

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2022-05-30
Completion
2022-06-30

Countries

  • Austria
  • Belgium
  • Denmark
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03437356 on ClinicalTrials.gov