Kansai Plus Atrial Fibrillation Trial

NCT01477983 | Completed Phase 4 DMC

• 1 other identifier: KPAFKUHP
• Study Type: interventional
• Target: 2,113
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure (EAST-AF Trial).

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; adenosine triphosphate; antiarrhythmic drugs

Outcome Measures

Primary Outcomes (1)

• Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy between 91 and 365 days after ablation. (Both trials)

  Atrial tachyarrhythmias include atrial fibrillation, atrial tachycardia, and common or uncommon atrial flutter. Antiarrhythmic drug (AAD) indicates Vaughan Williams class I or III drug.

  91 - 365 days

Secondary Outcomes (12)

• Repeat Ablation for atrial tachyarrhythmias. (Both trials)

  0 - 365 days

• Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* between 0 and 90 days after ablation. (Both trials)

  0 - 90 days

• Atrial tachyarrhythmias lasting for > 30 seconds or requiring repeat ablation, hospital admission, cardioversion or antiarrhythmic drug (AAD) therapy* after ablation. (Both trials)

  0 - 365 days

• Quality of Life (QOL) score. (Both trials)

  0 - 365 days

• Procedural complications including cardiac tamponade, thromboembolism, PV stenosis/occlusion, left atrium-esophageal fistula, and peri-esophageal injury. (UNDER-ATP trial)

  0 - 365 days

Study Arms (4)

ATP guide additional ablation - AAD

ACTIVE COMPARATOR

UNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: AAD for 90 days

Procedure: ATP guide additional ablation.; Drug: Antiarrhythmic drug (AAD)

Control - AAD

ACTIVE COMPARATOR

UNDER-ATP trial: Control, EAST-AF trial: AAD for 90 days

Procedure: Control; Drug: Antiarrhythmic drug (AAD)

ATP guide additinal ablation - Control

ACTIVE COMPARATOR

UNDER-ATP trial: ATP guide additional ablation, EAST-AF trial: Control

Procedure: ATP guide additional ablation.; Drug: Control

Control - Control

ACTIVE COMPARATOR

UNDER-ATP trial: Control, EAST-AF trial: Control

Procedure: Control; Drug: Control

Interventions

ATP guide additional ablation. PROCEDURE

Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.

Also known as: The brand names of ATP; Adetphos-L, Trinosin-S

ATP guide additional ablation - AAD

Antiarrhythmic drug (AAD) DRUG

Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.

Also known as: Brand names; Tambocor, Pronon, Sotacor, Ancaron

ATP guide additional ablation - AAD

Control DRUG

Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.

Also known as: Brand names; Tambocor, Pronon, Sotacor, Ancaron

ATP guide additinal ablation - Control

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing first catheter ablation including PV isolation for paroxysmal or persistent atrial fibrillation
• Patients who are 21-79 years old
• Able to be followed for one year in an out-patient clinic
• Willing to sign the consent form for participation

You may not qualify if:

• Contraindication or intolerance to adenosine triphosphate or Vaughan Williams class I or III antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation
• Age =\< 20 years or =\> 80 years
• Renal insufficiency (serum creatinine \>=2.0mg/dl or hemodialysis)
• NYHA class IV heart failure
• Left ventricular ejection fraction \< 40%
• Left atrial diameter \> 55mm
• Very long-lasting (\>=5years) persistent atrial fibrillation
• Ineligible for optimal anticoagulant therapy
• History of myocardial infarction within the past 6 months
• Prior or planned open heart surgery
• Severe valve heart disease
• Unable to be followed in an out-patient clinic for one year
• Unwilling to sign the consent form for participation
• When the attending physician are unwilling to enroll the patient in the study
• When the attending physician consider inappropriate to enroll the patient in the study

Sponsors & Collaborators

• Kyoto University, Graduate School of Medicine: lead

Study Sites (1)

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents; Flecainide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Satoshi Shizuta, MD

  Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Satoshi Shizuta, Kyoto University, Graduate School of Medicine

Study Record Dates

• First Submitted: November 12, 2011
• First Posted: November 23, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

JP (1)