A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy (CRYO-RF)

Herz-Zentrums Bad Krozingen

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation Ablation

Treatments: Procedure: PVI using an open irrigated tip catheter; Procedure: PVI using a cryoballoon; Procedure: PVI using a closed irrigated tip catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00773539

CRYO-BAD-KROZ

Details and patient eligibility

About

Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). However, rare but potentially life threatening complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation (13), preserves the extra cellular matrix and creates lesions with well-delineated border zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV isolation.

We therefore hypothesise that in the setting of PV isolation for the treatment of atrial fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory responses compared to radiofrequency energy.

78 patients presenting with symptomatic intermittent or persistent AF will be randomised to PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be monitored before, during and 48h after the procedure. Further endpoints include time to PV-isolation and procedure related complications. Six month clinical follow-up will focus on freedom from AF and cardiovascular events.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years
• Symptomatic drug refractory (more than 2 antiarrhythmic drugs) paroxysmal or persistent AF
• Documentation of AF on 12 lead ECG and/ or Holter
• Left atrium of less than 55 mm
• Informed consent signed by the patient

Exclusion criteria

• Previous Ablation or operation for AF
• Contra-indication for heart catheterisation
• Cardioversion for AF during the 2 weeks before the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

1

Active Comparator group

Treatment:

Procedure: PVI using an open irrigated tip catheter

2

Active Comparator group

Treatment:

Procedure: PVI using a closed irrigated tip catheter

3

Active Comparator group

Treatment:

Procedure: PVI using a cryoballoon