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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: AF ablation

• Registration Number: NCT04592497
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

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).

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study Start: 2020-10-15
• Last Update Submitted: 2020-10-18
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QDOT	AF ablation	will undergo the AF ablation procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system
standard	AF ablation	will undergo the AF ablation procedure with assistance standard Thermocool Smartouch SF system

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel