Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01276093
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2011-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB recommendation; enrollment too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAVANE
Brief Summary:
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.
Detailed Description:
Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.
Study Oversight
Has Oversight DMC:
True
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?: