Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT03854006
Status:
UNKNOWN
Last Update Posted:
2019-11-14
First Post:
2019-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
Sponsor:
Medical University of Lodz
Organization:
Study Overview
Official Title:
Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: