A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773539

Acronym

CRYO-RF

Enrollment

Registered

2008-10-16

Start date

2008-07-31

Completion date

2009-08-31

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Ablation

Keywords

atrial fibrillation, pulmonary veins, ablation

Brief summary

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.

Interventions

PROCEDUREPVI using an open irrigated tip catheter

transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block

PROCEDUREPVI using a closed irrigated tip catheter

transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block

PROCEDUREPVI using a cryoballoon

transseptal PVI using the cryoballoon from CRYOCATH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Changes of platelet function (number of patients with an increase of more than 100% in platelets positive for either P-selectin or activated GP IIb/IIIa)	before, at the end of intervention, 6, 24 and 48 hours later.

Secondary

Measure	Time frame
Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF.	before, during and 6 months after procedure

Countries

Germany

Contacts

Primary ContactThomas Arentz, MD

thomas.arentz@herzzentrum.de004976334020

Backup ContactDietmar Trenk

dietmar.trenk@herzzentrum.de004976334020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026