MedTrace Logo

PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)

NCT00774566 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2021-04-06

Study results available
· View outcomes & findings →

Summary

This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation technique (segmental isolation of the pulmonary veins) with radiofrequency energy. The primary study aim is to investigate whether the new cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of atrial arrhythmias without persistent complications after six and twelve months. Furthermore, the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during the procedure, levels of cardiac inflammatory markers are compared between the treatment groups. The short and long-term clinical success as well as the costs of both systems will also be evaluated.

Conditions

Interventions

PROCEDURE

PV-Isolation RF

Radiofrequency

PROCEDURE

PV-Isolation Cryo

Cryo-Balloon

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER

  • Staedtisches Klinikum Karlsruhe

    lead OTHER

Principal Investigators

  • Claus Schmitt, MD · Staedtisches Klinikum Karlsruhe

  • Armin Luik, MD · Staedtisches Klinikum Karlsruhe

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
2008-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

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 NCT00774566 on ClinicalTrials.gov