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

NCT ID: NCT04592497

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2022-10-01

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QDOT

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

Group Type: EXPERIMENTAL

AF ablation

Intervention Type: PROCEDURE

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.

standard

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

Group Type: ACTIVE_COMPARATOR

AF ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehud Chorin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ehud Chorin, MD PhD

Role: CONTACT

udichorin5@gmail.com

972527360498

Facility Contacts

Ehud Chorin, MD PhD

Role: primary

udichorin5@gmail.com

972527360498

Role: backup

mop@tasmc.health.gov.il

972-3-697-4761

Other Identifiers

TASMC-20-EC-488

Identifier Type: -

Identifier Source: org_study_id