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

NCT03854006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Cryoballoon pulmonary vein isolation

During cryoballoon pulmonary vein isolation, under local anaesthesia, diagnostic catheters are placed in the coronary sinus. The cryoballoon is advanced to the left atrium via a steerable sheath after single transseptal puncture and inflated at the PV(pulmonary vein) ostia. A spiral mapping catheter is advanced through the balloon inner lumen and positioned in the PV at the closest achievable proximity to the cryoballoon in order to record real-time PV potentials during PV isolation. During PV isolation the potentials from the PV are recorded. The TTI is defined as the time of the last recording of a PV potential before sustained isolation. Isolation of all PVs is reassessed at the end of the procedure by documentation of entrance- and exit-block.

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Andrzej Lubinski, MD, PhD · Medical University of Lodz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854006 on ClinicalTrials.gov