Esophageal Temperature During PVI Using Q-DOT Micro

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06392932
Status
Recruiting
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Conditions

  • Atrial Fibrillation Paroxysmal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QDOT Micro ablation catheter — DEVICE
    QDOT Micro ablation catheter
  • ST SF ablation catheter — DEVICE
    ST SF ablation catheter

Study Details

This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.

Key Dates

Start date
Oct 4, 2024
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QDOT Arm
    Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.
  • Active Comparator: ST SF Arm
    Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.

Primary Outcome Measure

Maximal change in esophageal temperature during posterior wall isolation. [ Time Frame: During ablation procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Smidt Heart InstituteLos AngelesCalifornia90048
Eric D Braunstein, MD
[email protected]
310-248-6679

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Smidt Heart Institute· Los Angeles, CA

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