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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: AF ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04592497

TASMC-20-EC-488

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

QDOT

Experimental group

Description:

will undergo the AF ablation procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system

Treatment:

Procedure: AF ablation

standard

Active Comparator group

Description:

will undergo the AF ablation procedure with assistance standard Thermocool Smartouch SF system

Treatment:

Procedure: AF ablation