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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04592497
• Other study ID #: TASMC-20-EC-488
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Atrial Fibrillation

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