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

November 13, 2019 updated by: Izabela Warchol, Medical University of Lodz

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Łódzkie
      • Łódź, Łódzkie, Poland, 90-549
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranów
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram

Exclusion Criteria:

Diagnosis of Sinus Rhythm on Electrocardiogram

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s

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.
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.
Active Comparator: Freeze cycle: TTI+120 s
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial Fibrillation Recurrence
Time Frame: 3 months after the procedure
3 months after the procedure
Atrial Fibrillation Recurrence
Time Frame: 12 months after the procedure
12 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Study Director: Andrzej Lubinski, MD, PhD, Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 23, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22012019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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