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Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation

NCT01803438 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-02-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

Conditions

  • Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases

Interventions

DEVICE

cryoballoon ablation system

DRUG

Antiarrhythmic Drugs

AAD therapy based on hospital clinical practice according to ESC Guidelines 2012

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Malte Kuniss, MD · Kerckhoff - Klinik, Bad Nauheim, Germany

  • GianBattista Chierchia, MD · Heart Rhythm Management Centre, UZ Brussels - VUB Brussel, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-10-16
Completion
2020-01-20

Countries

  • Argentina
  • Australia
  • Belgium
  • Croatia
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway

Study Locations

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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 NCT01803438 on ClinicalTrials.gov