Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison

Medical University of Lodz

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Cryoballoon pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT03854006

22012019

Details and patient eligibility

About

The purpose of this study is to develop and prospectively test two Cryo-AF (atrial fibrillation) dosing protocols guided exclusively by time-to-isolation (TT-I) in patients undergoing a first-time Cryo-AF.

Both protocols guided by TT-I are associated with shorter cryoapplications as compared to conventional approach.

In the first group freeze duration is TTI +120 s. In the second group freeze duration is 240s if TTI is < 75 s. In case of TTI>75s a 240s bonus freeze is applied.

The investigators examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.

The study cohort consists of consecutive patients undergoing a first-time Cryo-AF for symptomatic paroxysmal or persistent AF (atrial fibrillation) at Interventional Cadiology and Cardiac Arrhythmias Clinic of Medical University in Łódź. During 12 months investigators are planning to enroll 40 patients Patients are randomly assigned to the groups. All of them will be followed up 3 and 12 months after the procedure. In addition, ambulatory electrocardiographic monitoring will also be performed at 3 and 12 months.

The study is requested for an approval of the university ethics committee.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram

Exclusion criteria

Diagnosis of Sinus Rhythm on Electrocardiogram

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s

Active Comparator group

Description:

In the first group freeze duration is 240s if TTI (time-to-isolation) is \< 75 s. In case of TTI\>75s a 240s bonus freeze is applied. If no TTI could be documented, a single 240 s freeze cycle is applied in this group in case of balloon temperature -40°C (degrees Celsius) after 60 s.

Treatment:

Procedure: Cryoballoon pulmonary vein isolation

Freeze cycle: TTI+120 s

Active Comparator group

Description:

In the second group freeze duration is TTI (time-to-isolation) +120 s. If no TTI could be documented, a single 180 s freeze cycle is applied in this group in case of balloon temperature -40 °C after 60 s.

Treatment:

Procedure: Cryoballoon pulmonary vein isolation