Cryoablation for Ventricular Tachycardia

(FULCRUM-VT Trial)

Recruiting at14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Adagio Medical

Must be taking: Class III AAD

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a device that uses extreme cold to treat patients with a specific type of irregular heartbeat. It targets patients who have not responded to other treatments by freezing problematic heart tissue to stop abnormal signals.

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 data supports the effectiveness of the treatment Adagio VT Cryoablation System for ventricular tachycardia?

Research shows that cryoablation, a treatment that uses extreme cold to destroy abnormal heart tissue, is effective for treating ventricular tachycardia. In one study, cryoablation successfully stopped the abnormal heart rhythm in 93% of patients, and their heart function remained stable or improved after the procedure. ^{1 2 3 4 5}

Is cryoablation safe for treating ventricular tachycardia?

Cryoablation has been shown to be safe for treating various heart rhythm problems, including ventricular tachycardia, in humans. Studies indicate that it is a safe alternative to other treatments like radiofrequency ablation. ^{2 6 7 8 9}

How is the Adagio VT Cryoablation System treatment different from other treatments for ventricular tachycardia?

The Adagio VT Cryoablation System is unique because it uses cryoablation, which involves freezing the heart tissue causing the arrhythmia, unlike other treatments that may use heat. This method allows for precise targeting of the problematic area with minimal damage to surrounding tissues, and it can be performed on a beating heart, reducing the need for more invasive surgical procedures. ^{2 4 10 11 12}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Adagio VT Cryoablation System (Cryoablation)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Efficacy of cryosurgery alone for refractory monomorphic sustained ventricular tachycardia due to inferior wall infarction. [2019]

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

Transvenous cryoablation of cardiac arrhythmias. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cryoablation of junctional tachycardia at high risk of atrio-ventricular block. [2019]

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

Encircling endocardial cryoablation for ventricular tachycardia after myocardial infarction: experience with 33 patients. [2019]

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

The role of cryosurgery in the management of cardiac arrhythmias. [2019]

6. Mexico pubmed.ncbi.nlm.nih.gov

Catheter cryoablation of atrio-ventricular nodal reentrant tachycardia. A clinical review. [2010]

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

Electrogram characteristics at successful cryoablation sites in slow-fast atrioventricular nodal reentrant tachycardia. [2023]

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

Catheter cryoablation of the atrioventricular node in patients with atrial fibrillation: a novel technology for ablation of cardiac arrhythmias. [2019]

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

Catheter-based cryoablation of postinfarction and idiopathic ventricular tachycardia: initial experience in a selected population. [2012]

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

Surgery of tachyarrhythmia: intracardiac closed heart cryoablation. [2019]

11. Italy pubmed.ncbi.nlm.nih.gov

[Transcatheter cryoablation in children: state of the art]. [2012]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative electro-anatomical mapping and beating heart ablation of ventricular tachycardia. [2016]