ABLATOR Ablation Observational Registry (ABLATOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02344173|
Recruitment Status : Completed
First Posted : January 22, 2015
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|Condition or disease|
The objectives of this registry are the following:
- To confirm patient safety as part of the post market surveillance study.
- To assess performance of a combination of SJM products during procedures.
- To assess the learning curve with a combination of SJM products.
- To collect operator feedback on a combination of SJM products.
All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.
In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||2035 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||ABLATOR Ablation Observational Registry|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 18, 2017|
|Actual Study Completion Date :||August 18, 2017|
- Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. [ Time Frame: 12 months post procedure ]Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.
- Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. [ Time Frame: 12 months post procedure ]
Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to:
- A serious deterioration in the health of the subject
- Fetal distress, fetal death or a congenital abnormality or birth defect
A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344173
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