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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cryoballoon pulmonary vein isolation

• Registration Number: NCT03854006
• Lead Sponsor: Medical University of Lodz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-16
• Study First Submitted QC: 2019-02-23
• Study First Posted: 2019-02-26
• Study Start: 2019-05-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram

Read More

Exclusion Criteria

Diagnosis of Sinus Rhythm on Electrocardiogram

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s	Cryoballoon pulmonary vein isolation	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.
Freeze cycle: TTI+120 s	Cryoballoon pulmonary vein isolation	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.

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Recurrence	12 months after the procedure

Trial Locations

Locations (1)

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranów; 🇵🇱 Łódź, Łódzkie, Poland