Surgical Ablation for Atrial Fibrillation

Recruiting at 10 trial locations

Overseen By Jessica Halverson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must be taking: Anticoagulants

Disqualifiers: Wolff-Parkinson-White, NYHA Class IV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During index procedure

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of two handheld devices, Cardioblate and CryoFlex, in treating non-paroxysmal atrial fibrillation, a type of irregular heartbeat that remains constant. Surgeons use these devices during heart surgery to correct the irregular heartbeat through surgical ablation. Individuals with persistent AF who are already scheduled for heart surgery, such as bypass or valve surgery, may qualify. Participants must be able to take blood thinners like warfarin or similar medications. As an unphased trial, this study allows participants to contribute to groundbreaking research in surgical ablation technology.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to take anticoagulants like warfarin or NOACs (novel oral anticoagulants) to participate.

What prior data suggests that these devices are safe for treating atrial fibrillation?

Research has shown that the Cardioblate and CryoFlex devices are safe for treating atrial fibrillation (AF) and have received FDA approval since the early 2000s. This approval confirms their safety in other treatments.

Studies on surgical ablation for AF, which uses heat or cold to create small scars in the heart to stop abnormal electrical signals, report low complication rates. For instance, a large study found that a serious complication like fluid build-up around the heart (cardiac tamponade) occurred in only 0.7% of cases. This suggests that patients generally tolerate the procedure well.

In summary, both the Cardioblate and CryoFlex devices, along with surgical ablation procedures, have demonstrated safety for patients, with minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Cardioblate and Cryoflex handheld devices for surgical ablation in treating atrial fibrillation because these tools offer precision and versatility during cardiac surgery. Unlike traditional catheter ablation, these handheld devices allow surgeons to target problematic heart tissue directly and effectively during open-heart procedures. This approach integrates seamlessly with concomitant cardiac surgeries, potentially improving outcomes by addressing atrial fibrillation while the chest is already open for another procedure. By using these advanced devices, there's hope for more efficient and effective treatment of persistent and long-standing atrial fibrillation, which could lead to better patient recovery and reduced recurrence rates.

What evidence suggests that the Cardioblate and CryoFlex hand held devices are effective for non-paroxysmal atrial fibrillation?

Research has shown that surgical ablation, using devices like Cardioblate and CryoFlex, effectively treats atrial fibrillation (AF). Studies have found that surgical ablation successfully manages AF in over 70% of cases and is often more effective than catheter ablation for this condition. In this trial, participants will undergo surgical ablation with the Cardioblate and CryoFlex devices, designed to safely treat non-paroxysmal AF during heart surgery. These devices create small scars in the heart tissue, which help stop the irregular electrical signals causing AF. Overall, strong evidence supports the effectiveness of these treatments for atrial fibrillation. ^{1 2 4 6 7}

Who Is on the Research Team?

Ralph J Damiano, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with non-paroxysmal atrial fibrillation who need open-heart surgery, like bypass or valve repair. They must be able to take blood thinners like warfarin. People can't join if they have severe heart failure, are pregnant, have certain heart conditions or infections, need emergency surgery, or have a life expectancy under one year.

Inclusion Criteria

I have a long-term irregular heartbeat that doesn’t stop on its own.

I have had a valve repair or replacement surgery.

I need a planned open-heart surgery.

Exclusion Criteria

My heart condition severely limits my physical activity.

I need a heart pump or heart-strengthening medication before surgery.

I had a heart attack within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with the use of Cardioblate iRF and CryoFlex devices

During index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Post-procedure monitoring

Monitoring for freedom from AF/AFL/AT and adverse events

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cardioblate and Cryoflex hand held devices
• Surgical Ablation

Trial Overview The study tests the safety and effectiveness of two devices: Cardioblate iRF and CryoFlex. These handheld tools are used during non-emergency open-heart surgeries to treat persistent forms of atrial fibrillation that don't come and go on their own.

How Is the Trial Designed?

Group I: Primary Cohort Experimental Treatment 2 Interventions

Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery

Cardioblate and Cryoflex hand held devices is already approved in United States, European Union for the following indications:

Approved in United States as Cardioblate CryoFlex Surgical Ablation System for:

• Treatment of cardiac arrhythmias
• Minimally invasive cardiac surgical procedures

Approved in European Union as Cardioblate CryoFlex Surgical Ablation System for:

• Treatment of cardiac arrhythmias
• Minimally invasive cardiac surgical procedures

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Medtronic Cardiac Surgery

Lead Sponsor

Trials

10

Recruited

9,900+

Published Research Related to This Trial

The novel malleable cryoprobe demonstrated the ability to rapidly freeze cardiac tissue to clinically relevant temperatures, reaching -20°C in thicker tissues (up to 5 mm), which is crucial for effective treatment of atrial fibrillation.

In comparison to the existing rigid linear probe, the malleable probe showed superior ice formation capabilities, achieving lower temperatures at the probe's proximal end, indicating potential for improved efficacy in ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel cryoablation system: in vitro testing of heat capacity and freezing temperatures. Weimar, T., Lee, AM., Ray, S., et al.[2022]

The CoolLoop® cryoablation catheter was successfully used in 10 patients with paroxysmal atrial fibrillation, demonstrating feasibility in isolating pulmonary veins with a mean of 5.6 to 6.3 cryoablations per vein.

The procedure showed a good safety profile, with only one patient experiencing a groin hematoma and another having a brief episode of ST-elevation due to air embolism, while no other complications were reported during a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation. Stuehlinger, M., Hoenig, S., Spuller, K., et al.[2020]

The Cardioblate surgical ablation system utilizes saline-irrigated radiofrequency energy to create electrically isolating lines in atrial tissue, which is crucial for treating atrial fibrillation effectively.

This system provides a comprehensive approach to surgical ablation, showing promising results when compared to other energy sources and traditional methods like the Cox-Maze procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. Wahba, A.[2009]

The Cryo1 probe effectively created transmural lesions in the heart, achieving a 99% success rate in lesion formation, which is crucial for treating atrial fibrillation.

Both the Cryo1 and the 3011 Maze Linear probes demonstrated similar efficacy in lesion size and depth, indicating that either device can be used effectively for cryoablation in a porcine model of chronic atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel cryoablation system: in vivo testing in a chronic porcine model. Weimar, T., Lee, AM., Ray, S., et al.[2022]

Surgical treatment for atrial fibrillation, particularly through linear cryoablation, has been applied to 26 patients at our clinic, showing promising results despite the small sample size and short follow-up period.

The technique focuses on creating segments and channels in the atria to prevent reentry phenomena, with a shift towards less invasive methods targeting the pulmonary veins' orifice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of atrial fibrillation]. Lindner, J., Tosovský, J.[2006]

The first successful cryoablation procedure using a new device was performed on a patient with severe mitral valve insufficiency and paroxysmal atrial fibrillation, indicating a promising advancement in treatment options.

This new device addresses serious complications associated with existing surgical ablation tools, suggesting improved safety and efficacy for patients undergoing atrial fibrillation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new cryoablation device for surgical therapy of atrial fibrillation. Christiansen, S., Autschbach, R.[2016]

In a study of 63 patients undergoing cardiac procedures, argon-based cryoablation for atrial fibrillation (AF) was found to be safe and effective, achieving an 88.5% freedom from AF rate at 12 months.

The procedure had no in-hospital deaths or strokes, although 19% of patients required a permanent pacemaker post-surgery, indicating a generally positive safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. Mack, CA., Milla, F., Ko, W., et al.[2013]

The CryoCox-Maze III procedure, using an argon-based cryoablation system, showed a high success rate with 87% of patients maintaining sinus rhythm at 12 months, indicating its efficacy in treating atrial fibrillation.

The procedure demonstrated low operative mortality (<2%) and perioperative stroke rates (<1%), highlighting its safety, while improvements in quality of life and symptom severity were also reported, suggesting overall positive outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The concomitant cryosurgical Cox-Maze procedure using Argon based cryoprobes: 12 month results. Ad, N., Henry, L., Hunt, S.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03546374

NCT03546374 | Medtronic Terminate AF Study The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non- ...

2. withpower.com withpower.com/trial/phase-atrial-fibrillation-10-2018-c26ae

Surgical Ablation for Atrial Fibrillation The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non- ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01558635

Evaluation of the Cardioblate CryoFlex Surgical Ablation ... The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF. Detailed Description. Introduction: ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3966058/

Ablation Technology for the Surgical Treatment of Atrial ... The device is designed to be used in open or closed chest procedures. Medtronic has developed the Cardioblate Standard Ablation Pen and the Cardioblate XL ...

5. allclinicaltrials.com allclinicaltrials.com/study/NCT03546374

Medtronic Terminate AF Study The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of ...

6. news.medtronic.com news.medtronic.com/2018-12-03-Medtronic-Announces-First-Patient-Treated-in-TERMINATE-AF-Clinical-Trial

Medtronic Announces First Patient Treated in TERMINATE ... The Cardioblate Irrigated RF (IRF) and CryoFlex Surgical Ablation Systems received 510(k) clearance from FDA in 2000 and 2004, respectively ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT01558635/evaluation-of-the-cardioblate-cryoflex-surgical-ablation-system-in-longstanding-persistent-atrial-fibrillation

Evaluation of the Cardioblate CryoFlex Surgical Ablation ... This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat ...