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

NCT04592497 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-22

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ehud Chorin, MD PhD · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-10-01
Completion
2022-10-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592497 on ClinicalTrials.gov