Cryoablation for Ventricular Tachycardia

(FULCRUM-VT Trial)

Recruiting at 14 trial locations

Overseen By Doug Kurschinski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adagio Medical

Must be taking: Class III AAD

Disqualifiers: Congenital heart disease, Class IV heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

206 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of a new treatment called the Adagio VT Cryoablation System for individuals with Sustained Monomorphic Ventricular Tachycardia (SMVT), a type of abnormal heart rhythm. The procedure uses extreme cold to target and treat heart tissue responsible for the irregular heartbeat. It suits those who have experienced repeated SMVT episodes despite medication, have an ICD heart device, and can participate in follow-up checks. As an unphased trial, it provides patients the opportunity to access innovative treatment options and contribute to advancing medical research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be refractory to or intolerant of at least one Class III antiarrhythmic drug, which suggests that some medication changes might be necessary.

What prior data suggests that the Adagio VT Cryoablation System is safe for treating Sustained Monomorphic Ventricular Tachycardia?

Research has shown that the Adagio VT Cryoablation System is safe and effective for treating Ventricular Tachycardia, a type of fast heartbeat. One study successfully stopped the abnormal heartbeat in 97% of cases. Patients generally tolerate this system well. Another study found that using the device in everyday situations did not cause serious side effects. Overall, these findings suggest the treatment is safe for many people. However, like any medical procedure, risks may exist, so discussing expectations with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Adagio VT Cryoablation System is unique because it targets ventricular tachycardia (VT) using extreme cold to destroy the problematic heart tissue causing the arrhythmia. Unlike standard treatments like radiofrequency ablation, which use heat, this cryoablation technique might offer more precise control with potentially less damage to surrounding tissues. Researchers are excited about this approach because it could lead to fewer complications and improved safety for patients with VT. Additionally, this method might be particularly effective for patients with scar-related VT, potentially offering a new hope for those who have limited options.

What evidence suggests that the Adagio VT Cryoablation System is effective for treating Sustained Monomorphic Ventricular Tachycardia?

Studies have shown promising results for the Adagio VT Cryoablation System in treating Sustained Monomorphic Ventricular Tachycardia (SMVT). One study found that this treatment was 97% effective immediately for most patients. Research indicates that the system is both effective and safe for individuals with this heart condition. In early human trials, the treatment reduced episodes of abnormal heart rhythms associated with SMVT. In this trial, all enrolled patients will undergo an ablation procedure using the Adagio VT Cryoablation System. These findings suggest that the Adagio VT Cryoablation System could be a reliable option for managing this type of heart rhythm problem. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults (18+) with recurrent, symptomatic ventricular tachycardia linked to heart disease who've had an ICD implanted and are unresponsive or intolerant to certain medications. Participants must have a left ventricular ejection fraction of at least 20% and have experienced VT in the past 6 months. Exclusions include allergies to contrast dye, recent heart procedures, pregnancy, other conflicting medical conditions or treatments.

Inclusion Criteria

You have received an implantable cardioverter defibrillator (ICD) before joining the study.

I have had a bad reaction or no response to a specific heart medication.

My heart's pumping ability is at least 20%.

Exclusion Criteria

Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study

The doctor thinks you may not be a good fit for the study because of other health conditions, mental illness, addiction, or if you have a very serious illness or are expected to live less than a year.

I haven't had a stroke, mini-stroke, or blood clot (except DVT after surgery) in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Feasibility Study (EFS)

Initial phase to support device safety and effectiveness

During procedure

Pivotal Study

Collect safety and effectiveness data for future PMA marketing application

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Adagio VT Cryoablation System

Trial Overview The study tests the safety and effectiveness of the Adagio VT Cryoablation System for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). It involves using cold temperatures to destroy abnormal heart tissue causing rapid heartbeat.

How Is the Trial Designed?

Group I: VT Cryoablation Experimental Treatment 1 Intervention

all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT

Adagio VT Cryoablation System is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Adagio VT Cryoablation System for:

• Monomorphic Ventricular Tachycardia

Approved in United States as Adagio VT Cryoablation System for:

• Under investigation for Monomorphic Ventricular Tachycardia

Approved in Canada as Adagio VT Cryoablation System for:

• Under investigation for Monomorphic Ventricular Tachycardia

Who Is Running the Clinical Trial?

Adagio Medical

Lead Sponsor

Trials

8

Recruited

930+

Published Research Related to This Trial

The authors successfully introduced intracardiac cryoablation techniques for treating various tachyarrhythmias, achieving arrhythmia-free outcomes in 82%-100% of patients, demonstrating high efficacy.

Performing cryoablation without cardiopulmonary bypass (CPB) allows for continuous monitoring of heart activity, better control of ablation efficacy, and reduced surgical trauma, enhancing patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery of tachyarrhythmia: intracardiac closed heart cryoablation. Bredikis, JJ., Bredikis, AJ.[2019]

Cryoablation is a safe and effective method for treating AV-nodal reentry tachycardia, allowing for functional assessment of tissue before permanent ablation, which is particularly beneficial in high-risk areas.

While cryoablation shows slightly lower efficacy compared to radiofrequency ablation, it is recommended for high-risk procedures due to its safety profile, and further studies are needed to evaluate its long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter cryoablation of atrio-ventricular nodal reentrant tachycardia. A clinical review. Amara, W., De Sisti, A., Romero, L., et al.[2010]

Cryoablation is a new method for treating arrhythmias in pediatric patients that creates permanent lesions through low-temperature chilling, allowing for precise targeting of the heart tissue responsible for the arrhythmia.

This technique has shown an increased success rate over the last 3 years with no reported long-term complications, making it a preferred treatment option for specific types of tachycardia in school-age children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcatheter cryoablation in children: state of the art]. Russo, MS., Drago, F.[2012]

In a study of 45 patients with slow-fast AVNRT undergoing cryoablation, successful modification of the slow pathway was associated with a longer His(A)-SPP interval (86 ms) compared to unsuccessful sites (78 ms), indicating that this electrogram parameter is crucial for site selection.

The study found that a His(A)-SPP interval cutoff of 82 ms can predict successful cryoablation with a sensitivity of 67% and specificity of 71%, suggesting that this measurement can help improve the efficacy of cryoablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrogram characteristics at successful cryoablation sites in slow-fast atrioventricular nodal reentrant tachycardia. Watanabe, T., Yokoyama, Y., Hachiya, H., et al.[2023]

In a study of 26 patients with junctional tachycardia (JT) treated with cryoablation, the primary success rate was high at 92%, with no cases of permanent atrio-ventricular (AV) block reported, highlighting the safety of this approach.

The recurrence rate of tachycardia after cryoablation was 29% over an average follow-up of 9 months, which is higher than the 8.6% recurrence rate seen with radiofrequency (RF) ablation, suggesting that while cryoablation is effective, RF may offer better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation of junctional tachycardia at high risk of atrio-ventricular block. Nadji, G., Hermida, JS., Kubala, M., et al.[2019]

Cryoablation, initially thought to be a promising technique for treating cardiac arrhythmias, has become less commonly used over the years, primarily serving as an adjunctive therapy rather than a primary treatment option.

The technique's future may be more beneficial in cases requiring selective modification of heart tissue, particularly in managing AV nodal re-entrant tachycardia, where it could compete with newer catheter-based methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cryosurgery in the management of cardiac arrhythmias. Garratt, C., Camm, AJ.[2019]

Encircling endocardial cryoablation was performed on 33 patients with ventricular tachycardia (VT) and resulted in a significant long-term outcome, as all patients who were free of tachycardia at discharge remained alive and free of arrhythmias during a mean follow-up of 5 years.

Despite the procedure's success, some patients experienced complications, including postoperative congestive heart failure in 9 patients and one postoperative death, highlighting the need for careful patient selection and monitoring after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encircling endocardial cryoablation for ventricular tachycardia after myocardial infarction: experience with 33 patients. Guiraudon, GM., Thakur, RK., Klein, GJ., et al.[2019]

Surgical cryoablation for treating ventricular tachycardia can be effectively guided by real-time electro-anatomical mapping, demonstrating a promising approach when other therapies fail.

This case highlights the feasibility of using argon-based cryoablation on the beating heart to target ventricular tachycardia originating from the right ventricle, addressing challenges in surgical ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative electro-anatomical mapping and beating heart ablation of ventricular tachycardia. Bhavani, SS., Tchou, P., Chung, M., et al.[2016]

In a study of 159 patients with cardiac arrhythmias, transvenous cryoablation using a new cryotechnology system was found to be a safe and effective treatment for both supraventricular and ventricular tachycardia.

The outcomes of cryoablation were comparable to those achieved with traditional radiofrequency energy, showing similar effectiveness over long-term follow-ups of 15 months for supraventricular tachycardia and 9 months for ventricular tachycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous cryoablation of cardiac arrhythmias. Rodriguez, LM., Timmermans, C.[2017]

Catheter cryoablation of the atrioventricular node (AVN) was safely performed in 12 patients with refractory atrial fibrillation, achieving complete AVN block in 10 patients after an average of 4.8 cryoapplications.

Reversible cryomapping allowed for confirmation of successful ablation sites before permanent lesions were created, and no major complications were reported during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter cryoablation of the atrioventricular node in patients with atrial fibrillation: a novel technology for ablation of cardiac arrhythmias. Dubuc, M., Khairy, P., Rodriguez-Santiago, A., et al.[2019]

In a study of 17 patients, catheter-based cryoablation was found to be safe and effective for treating both postinfarction and idiopathic ventricular tachycardia, with no complications from the cryocatheter or cryoenergy observed.

After 6 months of follow-up, 40% of patients with postinfarction VT experienced a recurrence of their arrhythmia, while only 14% of those with idiopathic VT had a recurrence, indicating varying long-term outcomes based on the type of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter-based cryoablation of postinfarction and idiopathic ventricular tachycardia: initial experience in a selected population. Timmermans, C., Manusama, R., Alzand, B., et al.[2012]

Cryosurgery was highly effective in treating refractory ventricular tachycardias in 15 patients, with a clinical success rate of 93%, as it abolished inducible tachycardia in 11 patients and controlled it in 2 others with previously ineffective medication.

The procedure did not lead to deterioration in left ventricular function or significant mitral regurgitation, and there were no late deaths or recurrences of sustained ventricular tachycardia during an average follow-up of 19 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cryosurgery alone for refractory monomorphic sustained ventricular tachycardia due to inferior wall infarction. Cáceres, J., Werner, P., Jazayeri, M., et al.[2019]

Citations

1. investors.adagiomedical.com investors.adagiomedical.com/news-releases/news-release-details/adagio-medical-unveils-preliminary-acute-results-fulcrum-vt-us

Release Details - Investor Relations | Adagio Medical, Inc. 97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tachycardia. LAGUNA HILLS, Calif.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38582974/

Cryocure-VT: the safety and effectiveness of ultra-low- ... Conclusion: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05675865

Cryoablation for Monomorphic Ventricular Tachycardia A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio ...

4. medicaldevice-network.com medicaldevice-network.com/news/adagio-medical-vt/

Adagio Medical reports findings from ventricular ... Adagio Medical has reported preliminary acute efficacy and safety findings from its FULCRUM-VT Study, assessing the ULTC for treating SMVT.

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05675865

Cryoablation for Monomorphic Ventricular Tachycardia Description. Summary. The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X2300330X

Ultra-Low–Temperature Cryoablation for Ventricular ... This study is limited to acute efficacy and safety outcomes, with longer-term outcomes to become available upon completion of the CryoCure-VT (NCT04893317) ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)01625-9/fulltext

PO-05-034 CLINICAL CHARACTERISTICS AND ... We performed retrospective analysis of patients who had undergone VT ablation using the Adagio system. Follow up data on clinical outcomes and recurrence of VT ...