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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04592497
Other study ID # TASMC-20-EC-488
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date October 1, 2022

Study information

Verified date October 2020
Source Tel-Aviv Sourasky Medical Center
Contact Ehud Chorin, MD PhD
Phone 972527360498
Email udichorin5@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 1, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
AF ablation
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.

Locations

Country Name City State
Israel Tel Aviv Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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