Skip to main content
OpenTrials
Completed

NCT Number: NCT01360008

FREEZE Cohort Study

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines KH Linz, Linz, Austria

Loading trial locations.

About this study

Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)
  • First ablation of AF
  • Age ≥18 years
  • Documented inefficacy of at least 1 AAD not including β-blockers
  • Written informed consent

Exclusion criteria

  • Longstanding persistent AF lasting > 1 year
  • Acute coronary syndrome (ACS)
  • Heart failure NYHA IV
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Stroke or TIA within 6 months prior to ablation
  • Uncontrolled hyperthyroidism
  • Pregnancy
  • Life expectancy < 1 year

Treatment and study plan

Primary outcomes

  1. AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up

    Time frame: Admission to hospital until 12 months thereafter

Secondary outcomes

  1. Comparison of complication rates (any complications and major complications) at 12 months follow-up

    Time frame: Admission to hospital until 12 months thereafter

  2. Specific complication aspects with respect to phrenic nerve palsy and PV stenosis

    Time frame: Admission to Hospital until 12 months thereafter

  3. Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins

    Time frame: Admission to Hospital until 12 months thereafter

  4. Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI

    Time frame: Admission to Hospital until 12 months thereafter

  5. Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure

    Time frame: Admission to Hospital until 12 months thereafter

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
May 25, 2011
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.