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High Density Scar Guided Atrial Fibrillation Mapping (HD-SAGA)

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ClinicalTrials.gov Identifier: NCT03363087
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

There is increasing evidence that having AF is associated with some scarring of the upper chamber of the heart, the left atrium. There is also evidence that the amount of scarring can predict ablation success rates. Recently, rapid ultra high density mapping equipment has become available and this has the capability of defining the electrical scar in the atrium in detail. The equipment used to do this is standard approved equipment for the procedure but its use for making scar maps has not been fully assessed.

In the mapping phase of the study therefore, the aim will be to collect high density scar maps in AF and normal rhythm to see how they compare. Maps will be collected in different ways to see if that changes their accuracy. The study will also assess if the values previously suggested as representing scar with lower density mapping systems are still appropriate where high density mapping equipment is used. The results from this study will help to improve the understanding of scar in the atrium and help demonstrate the most efficient way to collect scar information using this high density mapping equipment. In the future, clinicians may be able to use these very detailed scar maps to tailor and refine the way they ablate patients with AF, though the focus of the current study is just on collecting the scar information.

While identifying areas requiring ablation is important to an ablation procedure, the other important aspect is the efficacy of ablation. Until now, we have been reliant on assessing our inputs into an ablation (such as the level of contact and the power delivered) but have been limited in the assessment of the output of an ablation in terms of lesion characteristics. New ablation catheter technology is now available which can assess the localised impedance drop with ablation. This is likely a better surrogate for lesion parameters than what we have previously had available and merits further study. Based on such study, we may be able to define targets for ablation which would help to guide future ablations.


Condition or disease Intervention/treatment
Atrial Fibrillation Device: Mapping and ablation

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Biatrial automated scar mapping in patients undergoing ablation for atrial fibrillation. Confirmation of scar by pacing in all patients. Collection of impedance data during clinical ablation.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Density Scar Guided Atrial Fibrillation Mapping
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mapping and ablation
Automated high density biatrial scar mapping Pacing confirmation of scar Collection of impedance data during clinical ablation
Device: Mapping and ablation
Ultra high density scar mapping Collection of impedance data during ablation


Outcome Measures

Primary Outcome Measures :
  1. Scar Volume [ Time Frame: Through study completion, an average of 1 year ]
    Quantification of scar volumes - presented as a proportion of the total atrial geometry volume

  2. Impedance values with ablation [ Time Frame: Through study completion, an average of 1 year ]
    Collection of localised and conventional impedance during ablation


Secondary Outcome Measures :
  1. Confirm Scar Thresholds [ Time Frame: Through study completion, an average of 1 year ]
    Pacing threshold in mV will be assessed at different levels of atrial scar

  2. Compare scar volumes in AF and sinus rhythm in the same patient [ Time Frame: Through study completion, an average of 1 year ]
    Quantitative comparison - comparing the scar areas in cm2 between the two maps

  3. Compare maps generated using internal unipolar reference and Wilson's Central Terminus [ Time Frame: Through study completion, an average of 1 year ]
    Quantitative comparison - comparing the scar areas in cm2 between the two maps

  4. Localised impedance fall during ablation [ Time Frame: Through study completion, an average of 1 year ]
    Compare the LI fall versus time relationship to assess the nature of the relationship with the aim of generating a target for LI fall with ablation

  5. Localised impedance fall versus electrogram attenuation [ Time Frame: Through study completion, an average of 1 year ]
    Compare the LI impedance fall with ablation with electrogram attenuation (on microelectrodes) to further provide evidence for an LI target

  6. Localised impedance fall versus pacing capture [ Time Frame: Through study completion, an average of 1 year ]
    Compare the LI impedance fall with ablation with loss of acing capture during ablation to further provide evidence for an LI target

  7. Compare localised with conventional impedance values during ablation [ Time Frame: Through study completion, an average of 1 year ]
    Compare localised with conventional impedance values during ablation


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • trial Fibrillation, Scheduled for ablation on clinical grounds Able/willing to consent to procedure/research protocol No contraindication to clinical ablation

Exclusion Criteria:

  • Unable/unwilling to consent Contraindication to clinical ablation
Contacts and Locations

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): NCT03363087


Contacts
Contact: Waqas Ullah, PhD 02380777222 ext 8128 waqas.ullah@uhs.nhs.uk

Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Boston Scientific Corporation
Investigators
Principal Investigator: Waqas Ullah, PhD University Hospital Southampton NHS Foundation Trust
More Information

Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03363087     History of Changes
Other Study ID Numbers: RHM CAR0523
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Atrial Scar
Atrial Fibrillation Ablation
Mapping
Persistent Atrial Fibrillation
Catheter Ablation

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