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ABLATOR Ablation Observational Registry (ABLATOR)

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ClinicalTrials.gov Identifier: NCT02344173
Recruitment Status : Unknown
Verified July 2016 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Condition or disease
Atrial Fibrillation

Detailed Description:

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
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who are indicated for an atrial fibrillation ablation procedure.
Criteria

Inclusion Criteria:

All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria:

Pregnant women.


Information from the National Library of Medicine

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


  Show 62 Study Locations
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02344173     History of Changes
Other Study ID Numbers: CRD_723
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes