High Density Scar Guided Atrial Fibrillation Mapping

NCT03363087 | Completed

• 1 other identifier: RHM CAR0523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

HD SAGA: 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. HD SAGA S: Approval amendment March 2021 In addition to the above, using new catheter technology incorporating contact force into the assessment of ablation lesion efficacy. HD SAGA H: Approval amendment March 2021 Using new mapping catheter (HD Grid) and algorithms (HD Wave) to compare scar maps between AF and SR and pre-establish pulmonary vein isolation lines.

Conditions

Atrial Fibrillation

Keywords

Atrial Scar; Atrial Fibrillation Ablation; Mapping; Persistent Atrial Fibrillation; Catheter Ablation

Outcome Measures

Primary Outcomes (3)

• Scar Volume

  Quantification of scar volumes - presented as a proportion of the total atrial geometry volume

  Through study completion, an average of 1 year

• Impedance values with ablation

  Collection of localised and conventional impedance during ablation

  Through study completion, an average of 1 year

• Scar volume and pulmonary vein isolation line gaps

  Scar volume and pulmonary vein isolation line gaps between AF and SR

  Through study completion, an average of 1 year

Secondary Outcomes (14)

• Confirm Scar Thresholds

  Through study completion, an average of 1 year

• Compare scar volumes in AF and sinus rhythm in the same patient

  Through study completion, an average of 1 year

• Compare maps generated using internal unipolar reference and Wilson's Central Terminus

  Through study completion, an average of 1 year

• Localised impedance fall during ablation

  Through study completion, an average of 1 year

• Localised impedance fall versus electrogram attenuation

  Through study completion, an average of 1 year

Study Arms (3)

Mapping (Rhythmia) and ablation (IntellaNav MiFi)

EXPERIMENTAL

Automated high density biatrial scar mapping Pacing confirmation of scar Collection of impedance data during clinical ablation

Device: Mapping and ablation

Mapping (Rhythmia) and ablation (StablePoint)

EXPERIMENTAL

Automated high density biatrial scar mapping Pacing confirmation of scar Collection of impedance data during clinical ablation Contact force measurements

Device: Mapping and ablation

Mapping (Precision)

EXPERIMENTAL

Automated high density left atrial mapping in AF and SR in different bipole orientations

Device: Mapping

Interventions

Mapping and ablation DEVICE

Ultra high density scar mapping Collection of impedance data during ablation

Mapping (Rhythmia) and ablation (IntellaNav MiFi); Mapping (Rhythmia) and ablation (StablePoint)

Mapping DEVICE

Omnipolar mapping of left atrial scar and pulmonary vein isolation lines

Mapping (Precision)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable/unwilling to consent Contraindication to clinical ablation

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Boston Scientific Corporation: collaborator
• Abbott: collaborator

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Waqas Ullah, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: December 6, 2017
• Study Start: August 27, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 18, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)