Ablation Catheters for Atrial Fibrillation

Overseen By Eric D Braunstein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Prior ablation, Unsafe Q-DOT, GI conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment QDOT MICRO Catheter for atrial fibrillation?

The QDOT MICRO Catheter has been shown to be effective and safe for treating atrial fibrillation and other heart rhythm issues. Studies like the FAST and FURIOUS series have demonstrated its ability to perform high-power, short-duration ablations, which can improve the procedure's success and safety. ^{1 2 3 4 5}

Is catheter ablation for atrial fibrillation generally safe?

Catheter ablation for atrial fibrillation is a common procedure, but it can have significant complications. Advances in technology have aimed to improve safety, but complication rates can vary depending on the specific device and procedure used. ^{6 7 8 9 10}

What makes the QDOT Micro treatment unique for atrial fibrillation?

The QDOT Micro treatment is unique because it uses a very high-power short-duration (vHPSD) approach, delivering 90 watts of energy for just 4 seconds, which improves the safety and effectiveness of the procedure. It also features real-time temperature control and contact force sensing, which helps streamline the ablation process and potentially increases the success rate of treating atrial fibrillation. ^{1 2 4 5 11}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with paroxysmal atrial fibrillation, a type of irregular heart rhythm. Participants should be eligible for catheter ablation, a procedure to correct the heart rhythm. Specific eligibility criteria are not provided but would typically include age range, overall health status, and absence of conditions that could complicate the procedure.

Inclusion Criteria

Provision of signed and dated informed consent form

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

I have been diagnosed with occasional irregular heartbeats.

Exclusion Criteria

Any records flagged 'break the glass' or 'research opt out.'

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

I have had a procedure done on the left side of my heart.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary vein isolation using either conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for esophageal temperature changes and injury, with assessments including post-procedure capsule endoscopy

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• QDOT Micro

Trial Overview The study is testing two different types of ablation catheters: ST SF and QDOT Micro. It aims to compare how each affects esophageal temperature during use in catheter ablation procedures and their risk of causing esophageal injury.

Participant Groups

Group I: QDOT Arm Experimental Treatment 1 Intervention

Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.

Group II: ST SF Arm Active Control 1 Intervention

Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.

QDOT Micro is already approved in United States, European Union for the following indications:

Approved in United States as QDOT Micro for:

• Paroxysmal atrial fibrillation

Approved in European Union as QDOT Micro for:

• Paroxysmal atrial fibrillation

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Findings from Research

The QDOT MICRO™ Catheter is a new radiofrequency ablation tool that uses high-power short-duration ablation (90 W for 4 seconds) to enhance the safety and effectiveness of procedures for treating arrhythmias.

It has been shown to be effective not only for pulmonary vein isolation (PVI) but also for various other arrhythmias, as demonstrated in studies like the FAST and FURIOUS series, indicating its versatility in cardiac treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very high-power short-duration catheter ablation for treatment of cardiac arrhythmias: Insights from the FAST and FURIOUS study series. Heeger, CH., Kuck, KH., Tilz, RR.[2023]

In a study involving 42 patients with symptomatic paroxysmal atrial fibrillation, the novel QDOT MICRO catheter achieved a 100% success rate in pulmonary vein isolation (PVI), indicating its efficacy in ablation procedures.

The catheter demonstrated an acceptable safety profile with only 4.8% of patients experiencing primary adverse events, and no serious complications like stroke or death, while also providing satisfactory performance feedback from physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temperature-Controlled Catheter Ablation for Paroxysmal Atrial Fibrillation: the QDOT-MICRO Workflow Sttudy. Potter, T., Grimaldi, M., Jensen, HK., et al.[2022]

Using the double repetitive application (DRA) method in vHPSD ablation resulted in the largest lesions compared to single (SA) and double nonrepetitive applications (DNRA), but it also increased the risk of steam-pops, which are bursts of steam that can occur during the procedure.

The double nonrepetitive application (DNRA) method produced larger lesions than single applications without raising the risk of steam-pops, making it a safer option for achieving effective ablation results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three different approaches to very high-power short-duration ablation using the QDOT-MICRO catheter. Yamaguchi, J., Takigawa, M., Goya, M., et al.[2023]

The QDOT Micro™ catheter, connected to a new radiofrequency generator, enhances the safety and efficacy of atrial fibrillation ablation by enabling temperature-controlled ablation, which adjusts power and irrigation based on tissue temperature.

This innovative approach allows for high-power short-duration ablation (up to 90 W for a few seconds), targeting new areas like the posterior wall and coronary sinus, which may improve outcomes for patients with persistent atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How an innovative catheter with temperature control and very high-power, short-duration ablation changed our approach to the treatment of persistent atrial fibrillation. Volpato, G., Compagnucci, P., Cipolletta, L., et al.[2023]

The QDOT MICRO catheter's temperature- and flow-controlled (TFC) very-high-power short-duration (vHPSD) ablation technique creates significantly larger and more effective lesions in the heart compared to standard power-controlled (PC) ablation, with larger focal lesions in both the atrium and right ventricle.

TFC/vHPSD ablation results in shallower, more homogeneous lesions with fewer complications, such as steam pops and smaller hemorrhagic rings, indicating a safer and more efficient method for cardiac ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temperature- and flow-controlled ablation/very-high-power short-duration ablation vs conventional power-controlled ablation: Comparison of focal and linear lesion characteristics. Takigawa, M., Kitamura, T., Martin, CA., et al.[2021]

A study of 86 patients with pacemakers and defibrillators undergoing atrial fibrillation (AF) ablation showed that the procedure is safe, with no significant changes in device function or increased complication rates compared to a control group.

The efficacy of AF ablation was similar in both groups, with recurrence rates of AF at 12 months being 19% for patients with devices and 21% for controls, indicating that AF ablation can be effectively performed in patients with implanted cardiac devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of radiofrequency energy catheter ablation of atrial fibrillation in patients with pacemakers and implantable cardiac defibrillators. Lakkireddy, D., Patel, D., Ryschon, K., et al.[2016]

The increasing number of patients with atrial fibrillation undergoing catheter ablation highlights the need for improved safety and efficiency in procedures, as the number of trained operators and lab capacity is limited.

Recent advancements in catheter-based ablation devices aim to enhance lesion durability and safety, while also reducing procedure time and radiation exposure, which could lead to better outcomes and lower complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Advances in Atrial Fibrillation Ablation Devices on the Incidence and Prevention of Complications. Keçe, F., Zeppenfeld, K., Trines, SA.[2020]

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

A systematic review of 89 studies involving 15,701 patients found that the overall complication rate for catheter ablation of atrial fibrillation (AF) is 4.51%, with severe complications occurring at a rate of 2.44%.

The complication rates have significantly decreased over the past decade, from 5.31% in earlier studies to 3.77% in more recent ones, indicating improved safety in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedure-Related Complications of Catheter Ablation for Atrial Fibrillation. Benali, K., Khairy, P., Hammache, N., et al.[2023]

In a study analyzing 14,875 atrial fibrillation ablation cases from 2015 to 2017, 7.2% of patients experienced complications, with a notable increase in complications over the years, particularly pericardial issues.

Key predictors of complications included older age, female gender, pulmonary hypertension, and chronic kidney disease, while hospitals with higher procedural volumes had lower complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. Wu, L., Narasimhan, B., Ho, KS., et al.[2022]

The QDOT Micro™ catheter is a new radiofrequency ablation device that enhances procedural efficiency and short-term safety through its advanced design, which includes temperature-sensing thermocouples and microelectrodes.

Initial results from preclinical and clinical settings show promise, but further studies are needed to confirm its long-term effectiveness and to assess the quality of lesions it produces compared to other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosense Webster's QDOT Micro™ radiofrequency ablation catheter. Wielandts, JY., Almorad, A., Hilfiker, G., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Very high-power short-duration catheter ablation for treatment of cardiac arrhythmias: Insights from the FAST and FURIOUS study series. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Temperature-Controlled Catheter Ablation for Paroxysmal Atrial Fibrillation: the QDOT-MICRO Workflow Sttudy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of three different approaches to very high-power short-duration ablation using the QDOT-MICRO catheter. [2023]

4. England pubmed.ncbi.nlm.nih.gov

How an innovative catheter with temperature control and very high-power, short-duration ablation changed our approach to the treatment of persistent atrial fibrillation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Temperature- and flow-controlled ablation/very-high-power short-duration ablation vs conventional power-controlled ablation: Comparison of focal and linear lesion characteristics. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of radiofrequency energy catheter ablation of atrial fibrillation in patients with pacemakers and implantable cardiac defibrillators. [2016]

7. England pubmed.ncbi.nlm.nih.gov

The Impact of Advances in Atrial Fibrillation Ablation Devices on the Incidence and Prevention of Complications. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Procedure-Related Complications of Catheter Ablation for Atrial Fibrillation. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Biosense Webster's QDOT Micro™ radiofrequency ablation catheter. [2022]