Lesion Contiguity in Very High Power-short Duration Ablation

NCT ID: NCT05368610

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Till F. Althoff

Staff, Arrhythmia Section, Department of Cardiology, Hospital Clinic de Barcelona

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Till F. Althoff, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, University of Barcelona

Locations

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Hospital Clinic, University of Barcelona

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Till F. Althoff, M.D.

Role: CONTACT

+34932271778

Lluis Mont, M.D., Ph.D.

Role: CONTACT

+34932275551

Facility Contacts

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Lluis Mont

Role: primary

+34 93 2271778

Neus Portella

Role: backup

+34 93 2271778

Other Identifiers

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QDOT-MRI

Identifier Type: -

Identifier Source: org_study_id

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