Atrial FibrillationNCT03854006
Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
A study testing Cryoballoon pulmonary vein isolation in people with Atrial Fibrillation, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoballoon pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2019to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram
Who cannot join
- Diagnosis of Sinus Rhythm on Electrocardiogram
Trial locations and contacts
1 site in 1 country.
Tomasz Kucejko contact
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranów
Lodz, Łódź Voivodeship, 90-549
Izabela Warchoł, 794982391 ext. +48, izabelaritawarchol@gmail.com
About this study
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.
Read more
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
- Atrial Fibrillation
- Being tested
- Cryoballoon pulmonary vein isolation
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon pulmonary vein isolationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s | Active comparator | 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. Receives: Procedure: Cryoballoon pulmonary vein isolation |
| Freeze cycle: TTI+120 s | Active comparator | 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. Receives: Procedure: Cryoballoon pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Recurrence
Measured: 3 months after the procedure
Atrial Fibrillation Recurrence
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 May 2019
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izabela Warchol, Medical University of Lodz
- Investigators
- Andrzej Lubinski, MD, PhD, Study director, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854006
- Sponsor's protocol ID
- 22012019
- Status last verified
- Nov 2019
- First submitted
- 16 Feb 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
- ClinicalTrials.gov ID
- NCT03854006
- Acronym / sponsor ID
- 22012019
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.
| Arm | Type | Receives |
|---|---|---|
| Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s | Active comparator | Procedure: Cryoballoon pulmonary vein isolationIn 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 | Active comparator | Procedure: Cryoballoon pulmonary vein isolationIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram
Key exclusion criteria (1 listed)
- Diagnosis of Sinus Rhythm on Electrocardiogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon pulmonary vein isolationDuring 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. | Procedure or surgery | Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s, Freeze cycle: TTI+120 s |
Primary outcome
Atrial Fibrillation Recurrence
Time frame: 3 months after the procedure
Atrial Fibrillation Recurrence
Time frame: 12 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Kucejko contact
Andrzej Lubinski, MD, PhD study director
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon pulmonary vein isolation in people with Atrial Fibrillation, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izabela Warchoł (794982391 ext. +48, izabelaritawarchol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Recurrence (time frame: 3 months after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.