Surgical Ablation for Atrial Fibrillation

Recruiting at 11 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

Trial Summary

What is the purpose of this trial?

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-paroxysmal AF.

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 data supports the effectiveness of the treatment Surgical Ablation for Atrial Fibrillation?

Research shows that the Cardioblate surgical ablation system, which uses radiofrequency energy, is effective in treating atrial fibrillation by creating isolating lines in heart tissue. Additionally, new cryoablation devices have been successfully used in patients with atrial fibrillation, suggesting these treatments can be effective. ^{1 2 3 4 5}

Is surgical ablation for atrial fibrillation safe for humans?

Surgical ablation for atrial fibrillation, including methods like cryoablation and radiofrequency ablation, has been used in humans with some success. However, there have been reports of serious complications with some devices, leading to the development of new tools to improve safety. ^{1 3 6 7 8}

How is the Surgical Ablation treatment for atrial fibrillation unique?

The Surgical Ablation treatment for atrial fibrillation is unique because it uses devices like the Cardioblate system to create electrically isolating lines in the heart tissue using saline-irrigated radiofrequency energy, which can be less invasive compared to traditional surgical methods. Additionally, the use of cryoablation (freezing technique) offers an alternative to incisions, potentially reducing complications and improving outcomes. ^{1 2 3 4 5}

Research Team

Ralph J Damiano, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A new cryoablation device for surgical therapy of atrial fibrillation. [2016]

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

Evaluation of a novel cryoablation system: in vitro testing of heat capacity and freezing temperatures. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. [2009]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Surgical treatment of atrial fibrillation]. [2006]

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

Evaluation of a novel cryoablation system: in vivo testing in a chronic porcine model. [2022]

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

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. [2013]

7. Italy pubmed.ncbi.nlm.nih.gov

The concomitant cryosurgical Cox-Maze procedure using Argon based cryoprobes: 12 month results. [2016]

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

CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation. [2020]