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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QDOT | Experimental | will undergo the AF ablation procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system |
|
| standard | Active Comparator | will undergo the AF ablation procedure with assistance standard Thermocool Smartouch SF system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF ablation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehud Chorin, MD PhD | Contact | 972527360498 | udichorin5@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ehud Chorin, MD PhD | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center | Tel Aviv | Israel |
The results of the study will be submitted to a peer-reviewed journal in the field of cardiac arrhythmia
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |