Overview

This trial is active, not recruiting.

Condition arrhythmia
Sponsor Stiftung Institut fuer Herzinfarktforschung
Collaborator Medtronic
Start date April 2011
End date January 2016
Trial size 4071 participants
Trial identifier NCT01360008, FREEZE

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with first Ablation of atrial fibrillation treated by cryo ablation
Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation

Primary Outcomes

Measure
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

Measure
Comparison of complication rates (any complications and major complications) at 12 months follow-up
time frame: Admission to hospital until 12 months thereafter
Specific complication aspects with respect to phrenic nerve palsy and PV stenosis
time frame: Admission to Hospital until 12 months thereafter
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
Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI
time frame: Admission to Hospital until 12 months thereafter
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title FREEZE Cohort Study
Principal investigator Ellen Hoffmann, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stiftung Institut fuer Herzinfarktforschung.