Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT02074566
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2014-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Sponsor:
Harald Verheij
Organization:
Study Overview
Official Title:
A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
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:
Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Detailed Description:
Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
Main study parameters/endpoints Acute success of pulmonary vein isolation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
Main study parameters/endpoints Acute success of pulmonary vein isolation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: