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 : Unknown
Verified July 2016 by Abbott Medical Devices.
Recruitment status was: Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : July 22, 2016
|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 :||2007 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||ABLATOR Ablation Observational Registry|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||May 2018|
- Performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation. [ Time Frame: after follow-up of 12 months ]performance and clinical effectiveness
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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