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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of ablation catheters to assess their impact on the esophagus's temperature and risk of injury during atrial fibrillation treatment. One group will use the QDOT Micro catheter, which applies a high-power short burst of heat, while the other group will use a conventional method. Candidates include those diagnosed with paroxysmal atrial fibrillation who are scheduled for a specific heart procedure. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that these ablation catheters are safe for atrial fibrillation treatment?

Studies have shown that the QDOT Micro catheter, used to remove heart tissue, is generally safe. Research indicates that procedures with this catheter are quicker and may require less pain medication, suggesting good tolerance of the treatment. Some studies reported very few serious complications, such as a small tear in the heart, but these were rare, occurring in only a small number of cases out of many procedures. Overall, evidence suggests that the QDOT Micro catheter is safe for patients with atrial fibrillation when used by experienced doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the QDOT Micro treatment for atrial fibrillation because it offers a unique approach with its temperature-controlled very-high-power short-duration ablation technique. Unlike conventional methods that use high-power ablation over longer durations, QDOT Micro potentially reduces procedure times and enhances precision, minimizing damage to surrounding tissues. This innovative approach aims to improve the effectiveness and safety of ablation procedures, offering new hope for patients with atrial fibrillation.

What evidence suggests that these ablation strategies are effective for atrial fibrillation?

This trial will compare the QDOT Micro catheter with the ThermoCool ST SF catheter for treating paroxysmal atrial fibrillation (AF). Studies have shown that the QDOT Micro catheter works well for this type of irregular heartbeat. Research indicates that this catheter greatly improves patients' quality of life and reduces their need for medical care. One study found that AF returned in only about 15% of patients using the QDOT Micro, compared to about 31% with another method. Procedures with the QDOT Micro also take up to 48% less time, suggesting that it is both efficient and effective for managing AF. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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'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]

Citations

1. innovationsincrm.com innovationsincrm.com/latest-news/2124-new-data-published-on-biosense-webster-qdot-micro-catheter

New Data Published on Biosense Webster QDOT MICRO ... Real World Evidence studies with the QDOT MICRO™ Catheter demonstrated that procedures with QDOT MICRO™ were 48% shorter on average with QMODE+™ and 36% shorter ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210027B.pdf

summary of safety and effectiveness data (ssed) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of percutaneous catheter ablation with the QDOT MICRO™ ...

3. jnjmedtech.com jnjmedtech.com/en-US/q-fficiency-study-qdot-micro-catheter

Q-FFICIENCY Study (QDOT MICRO Catheter) Safe, efficient, and effective paroxysmal AF treatment with significantly improved quality-of-life and reduced healthcare utilization.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11374326/

Safety and effectiveness of very-high-power, short-duration ... Results. Atrial fibrillation was found to recur in 14.81% of patients in the vHPSD-group and in 31.48% of patients in the AI-group (p = 0.07). There was no ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03775512

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein ... Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an ...

6. jnjmedtech.com jnjmedtech.com/en-US/news-events/new-data-published-biosense-webster-qdot-micro-catheter-latest-advancement-focal-rf

New Data Published on Biosense Webster QDOT MICRO ... Real World Evidence studies with the QDOT MICRO™ Catheter demonstrated that procedures with QDOT MICRO™ were 48% shorter on average with QMODE+™ ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03775512

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein ... Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.123.012643

Cardiac Perforation During High-Power Radiofrequency ... Up to the third complication, these operators performed a combined 189 atrial fibrillation ablations using QDot (63% of our practice's total), translating to a ...