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Lesion Contiguity in Very High Power-short Duration Ablation

Sponsor
University of Barcelona (Other)
Overall Status
Recruiting
CT.gov ID
NCT05368610
Collaborator
(none)
128
Enrollment
1
Location
14.7
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    128 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance
    Actual Study Start Date :
    Mar 10, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Very high power-short duration ablation

    PVI performed by point-by-point very high power-short duration radiofrequency ablation (QDOT-micro catheter, Biosense Webster; Qmode+; 90 W; 4 sec; target intertag distances: posterior wall 4 mm, proximity of the esophagus 5 mm, all other 3 mm)
    Matched control group conventional ablation

    PVI performed by conventional point-by-point radiofrequency ablation (40 W; ablation index-guided: posterior wall 350, other 450; target intertag distance 3.0 - 5.0 mm)

    Outcome Measures

    Primary Outcome Measures

    1. Ablation lesion contiguity as assessed by LGE-CMR [LGE-CMR at 3 months post-ablation]

      Proportion of the circumferential ablation line covered by LGE (%)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • paroxysmal or early persistent (max. 3 months) atrial fibrillation

    • scheduled for PVI-only catheter ablation

    Exclusion Criteria:

    • long-standing persistent atrial fibrillation

    • previous left atrial ablation

    • claustrophobia preventing CMR

    • sever renal insufficiency (GFR >30 ml/min)

    • gadolinium contrast allergy

    • presence of implantable devices not compatible with magnetic resonance

    • pregnancy and lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinic, University of Barcelona Barcelona Catalonia Spain 08036

    Sponsors and Collaborators

    • University of Barcelona

    Investigators

    • Principal Investigator: Till F. Althoff, M.D., Hospital Clinic, University of Barcelona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Till F. Althoff, Staff, Arrhythmia Section, Department of Cardiology, Hospital Clinic de Barcelona, University of Barcelona
    ClinicalTrials.gov Identifier:
    NCT05368610
    Other Study ID Numbers:
    • QDOT-MRI
    First Posted:
    May 10, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Till F. Althoff, Staff, Arrhythmia Section, Department of Cardiology, Hospital Clinic de Barcelona, University of Barcelona
    Catheter ablation
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 10, 2022