Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 22, 2020
October 1, 2020
12 months
October 14, 2020
October 18, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
procedure time
The procedural and fluoroscopy time required for the procedure (in minutes).
1 day
isolation efficacy
The first time pulmonary vein isolation (percentages of success)
1 day
Recurrence of AF
Recurrence of AF (will be assessed by Holter monitoring)
1 year
Study Arms (2)
QDOT
EXPERIMENTALwill undergo the AF ablation procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system
standard
ACTIVE COMPARATORwill undergo the AF ablation procedure with assistance standard Thermocool Smartouch SF system
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant women.
- Patients with iodine contrast media allergy
- Patients with renal failure (GFR \<60ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ehud Chorin, MD PhD
Tel Aviv Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 14, 2020
First Posted
October 19, 2020
Study Start
October 15, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
The results of the study will be submitted to a peer-reviewed journal in the field of cardiac arrhythmia