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Personalized Atrial Fibrillation Ablation With QDOT

NCT04298177 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-08-30

No results posted yet for this study

Summary

Circumferential pulmonary vein isolation (PVI) has become a mainstay in the treatment of atrial fibrillation (AF), particularly in symptomatic patients with paroxysmal AF (PAF) intolerant or refractory to medical treatment. The safety and short-term performance of the novel QDOT® catheter (Biosense Webster, Irvine, CA, USA), that allows for a high-power short-duration (HPSD) ablation, has already been evaluated in the QDOT-FAST clinical study, with favorable data on feasibility and safety, and lowered fluoroscopy and procedure times needed to achieve complete PVI. HPSD ablation was based on immediate heat formation during the resistive phase, affecting a small tissue depth at 90 W/4 s (irrigation at 8 ml/min) with a temperature limit of 65ºC.

However, up to date there are no randomized studies evaluating the real usefulness of the QDOT® catheter. Longer-term follow-up is still required to verify the long-term effectiveness and correlations between short-term follow-up and arrhythmia recurrence when using this catheter. The impact of this novel catheter, when used in conjunction with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT) to modulate the AI target at each ablation point, compared with a standard ablation protocol following the published CLOSE study criteria is already unknown.

Conditions

Interventions

DEVICE

Atrial fibrillation ablation using the QDOT® catheter

Atrial fibrillation ablation will be performed using the QDOT® catheter. The ablation mode will be selected according to the MDCT-derived LAWT information.

PROCEDURE

Standard atrial fibrillation ablation

Atrial fibrillation ablation will be performed using the SmartTouch® catheter. The ablation parameters will be adjusted according to the settings previously described in the CLOSE study.

Sponsors & Collaborators

  • Antonio Berruezo, MD, PhD

    lead OTHER

Principal Investigators

  • Antonio Berruezo, MD, PhD · Centro Medico Teknon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-12-01
Completion
2023-12-30
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298177 on ClinicalTrials.gov