RECRUITING

Esophageal Temperature During PVI Using Q-DOT Micro

Conditions

Atrial Fibrillation Paroxysmal Atrial Fibrillation Esophageal thermal injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-04

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06392932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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."

Inclusion Criteria

Exclusion 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

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."

Contacts and Locations

Study Contact

Eric D Braunstein, MD

CONTACT

310-248-6679

Eric.Braunstein@cshs.org

Tansy Aguilar

CONTACT

tansy.aguilar@cshs.org

Study Locations (Sites)

Cedars-Sinai Smidt Heart Institute

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-10-04

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Atrial Fibrillation
Esophageal thermal injury

Additional Relevant MeSH Terms

Atrial Fibrillation Paroxysmal