Atrial Fibrillation ParoxysmalNCT06392932
Esophageal Temperature During PVI Using Q-DOT Micro
A study testing QDOT Micro ablation catheter and ST SF ablation catheter in people with Atrial Fibrillation Paroxysmal, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- QDOT Micro ablation catheter and ST SF ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged greater than or equal to 18 years
- Diagnosed with paroxysmal atrial fibrillation
- 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
Who cannot join
- Patients who have undergone prior left atrial ablation procedures.
- 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.
- 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)
- Any records flagged "break the glass" or "research opt out."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tansy Aguilar contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Smidt Heart Institute
Los Angeles, California, 90048
Eric D Braunstein, MD, 310-248-6679, Eric.Braunstein@cshs.org
About this study
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
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- QDOT Micro ablation catheter, ST SF ablation catheter
- Keywords
- Atrial Fibrillation, Esophageal thermal injury
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QDOT Micro ablation catheterDevice
QDOT Micro ablation catheter
ST SF ablation catheterDevice
ST SF ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| QDOT Arm | Experimental | Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter. Receives: Device: QDOT Micro ablation catheter |
| ST SF Arm | Active comparator | Conventional high-power short-duration ablation using the ThermoCool ST SF catheter. Receives: Device: ST SF ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal change in esophageal temperature during posterior wall isolation.
Measured: During ablation procedure.
Secondary outcomes (2)
Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.
Measured: 2-4 days after ablation procedure.
Presence of procedural complications.
Measured: During and immediately following ablation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start4 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open-label randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Eric Braunstein, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392932
- Sponsor's protocol ID
- STUDY00002707
- Status last verified
- Oct 2025
- First submitted
- 26 Apr 2024
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06392932
- Acronym / sponsor ID
- STUDY00002707
- Conditions
- Atrial Fibrillation Paroxysmal
- Keywords
- Atrial Fibrillation, Esophageal thermal injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| QDOT Arm | Experimental | Device: QDOT Micro ablation catheterTemperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter. |
| ST SF Arm | Active comparator | Device: ST SF ablation catheterConventional high-power short-duration ablation using the ThermoCool ST SF catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged greater than or equal to 18 years
- Diagnosed with paroxysmal atrial fibrillation
- 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
Key exclusion criteria (4 listed)
- Patients who have undergone prior left atrial ablation procedures.
- 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.
- 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)
- Any records flagged "break the glass" or "research opt out."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QDOT Micro ablation catheterQDOT Micro ablation catheter | Device | QDOT Arm |
| ST SF ablation catheterST SF ablation catheter | Device | ST SF Arm |
Primary outcome
Maximal change in esophageal temperature during posterior wall isolation.
Time frame: During ablation procedure.
2 secondary outcomes
Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.
Time frame: 2-4 days after ablation procedure.
Presence of procedural complications.
Time frame: During and immediately following ablation procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tansy Aguilar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QDOT Micro ablation catheter and ST SF ablation catheter in people with Atrial Fibrillation Paroxysmal, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric D Braunstein, MD (310-248-6679, Eric.Braunstein@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal change in esophageal temperature during posterior wall isolation. (time frame: During ablation procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.