Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT

Study Overview
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Brief Summary
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The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

Detailed Description
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The very high power-short duration (vHPSD) catheter, is a novel CF catheter optimized for temperature-controlled ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring during ablation. The associated vHPSD algorithm modulates power to maintain target temperature during these vHPSD lesions (90 W, 4 s). In preclinical models, vHPSD ablation with this novel catheter has improved atrial linear lesion contiguity, transmurality, and durability and has substantially reduced radiofrequency ablation times, but with a safety profile similar to those of standard irrigated radiofrequency ablation catheters. The QDOT -FAST study demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

Official Title
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Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT Strategy in Patients Referred for Atrial Fibrillation Ablation.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: AF ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female >18 years old. Subjects must provide written informed consent to participate in the study. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. Exclusion Criteria: Pregnant women. Patients with iodine contrast media allergy Patients with renal failure (GFR <60ml/min)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QDOT<br>will undergo the AF ablation procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system | Procedure: AF ablation<br>* Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. One group will undergo the procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system and the other with the standard Thermocool Smartouch SF system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Data will be anonymized by removing patient protected health information, only initials will be used.<br>|
| Active Comparator: standard<br>will undergo the AF ablation procedure with assistance standard Thermocool Smartouch SF system | Procedure: AF ablation<br>* Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. One group will undergo the procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system and the other with the standard Thermocool Smartouch SF system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Data will be anonymized by removing patient protected health information, only initials will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | The procedural and fluoroscopy time required for the procedure (in minutes). | 1 day | 
| isolation efficacy | The first time pulmonary vein isolation (percentages of success) | 1 day | 
| Recurrence of AF | Recurrence of AF (will be assessed by Holter monitoring) | 1 year |