Status:
UNKNOWN
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Lead Sponsor:
Luigi Sacco University Hospital
Collaborating Sponsors:
Centro Cardiologico Monzino
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a g...
Eligibility Criteria
Inclusion
- Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- Patients presenting with Persistent AF with AF duration \< 2 years scheduled to undergo a PVAI procedure
- Age range of 18 - 85 years
- Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion
- Congenital heart disease, age younger than 18 years, significant valve disease, LA size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or New York Heart Association class IV).
- Presence of a mechanical prosthetic valve.
- Secondary causes of atrial fibrillation
- Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
- Social factors that would preclude follow up or make compliance difficult.-
- Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT03365700
Start Date
February 1 2018
End Date
August 1 2020
Last Update
February 23 2018
Active Locations (3)
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1
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan, Italy
2
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Milan, Italy
3
Istituto Clinico S. Ambrogio
Milan, Italy