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FIRE AND ICE II Trial Pilot

NCT03706677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-11-29

No results posted yet for this study

Summary

The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

Conditions

  • Persistent Atrial Fibrillation
  • Atrial Arrhythmia

Interventions

DEVICE

Cryoballoon (Arctic Front Advance Cryoballoon)

Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)

DEVICE

Radiofrequency Catheter (ThermoCool Smarttouch)

Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)

Sponsors & Collaborators

  • genae associates (CRO), Antwerp, Belgium

    collaborator UNKNOWN

  • King's College London

    collaborator OTHER

  • Deutsches Herzzentrum Muenchen

    collaborator OTHER

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Karl-Heinz Kuck, Prof. Dr. · Asklepios St. Georg, Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2023-04-06
Completion
2023-04-06

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT03706677 on ClinicalTrials.gov