Esophageal Temperature During PVI Using Q-DOT Micro

Atrial Fibrillation Paroxysmal Clinical Trial

Official title:

Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392932
• Other study ID #: STUDY00002707
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Eric D Braunstein, MD
• Phone: 310-248-6679
• Email: Eric.Braunstein[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged greater than or equal to 18 years

4. Diagnosed with paroxysmal atrial fibrillation

5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

Exclusion Criteria:

1. Patients who have undergone prior left atrial ablation procedures.

2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.

3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)

4. Any records flagged "break the glass" or "research opt out."

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal

Intervention

Device:
• QDOT Micro ablation catheter
QDOT Micro ablation catheter
• ST SF ablation catheter
ST SF ablation catheter

Locations

Country	Name	City	State
United States	Cedars-Sinai Smidt Heart Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of RF ablation lesions to performed pulmonary vein isolation.		During ablation procedure.
Other	RF time during pulmonary vein isolation.		During ablation procedure.
Other	Left atrial dwell time to achieve pulmonary vein isolation.		During ablation procedure.
Other	Achievement of first pass pulmonary vein isolation.		During ablation procedure.
Primary	Maximal change in esophageal temperature during posterior wall isolation.		During ablation procedure.
Secondary	Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.		2-4 days after ablation procedure.
Secondary	Presence of procedural complications.		During and immediately following ablation procedure.