Surgical Ablation for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiovascular
No Placebo Group
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.
12345Is 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.
13678How 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.
12345Eligibility 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.
I need a planned open-heart surgery, like bypass or valve repair.
I can take warfarin or other new oral blood thinners.
Exclusion Criteria
My heart condition severely limits my physical activity.
I need a heart pump or heart-strengthening medication before surgery.
I need urgent heart surgery or a repeat open heart surgery.
I have Wolff-Parkinson-White syndrome.
I am on dialysis for kidney failure or have liver failure.
I have an ongoing heart infection.
I have had a procedure to correct my irregular heartbeat.
My heart's pumping ability is significantly reduced.
I am currently diagnosed with an active infection.
I cannot take blood thinners due to health reasons.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Primary CohortExperimental Treatment2 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Intermountain Medical CenterMurray, UT
Spectrum Health HospitalsGrand Rapids, MI
Allegheny General HospitalPittsburgh, PA
ProMedica ToledoToledo, OH
More Trial Locations
Loading ...
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
Medtronic Cardiac SurgeryLead Sponsor
References
A new cryoablation device for surgical therapy of atrial fibrillation. [2016]During the last years, atrial fibrillation was treated more and more by surgical ablation. Due to serious complications with the available devices, new tools were developed. We report on the first successful cryoablation procedure with a new device in a patient with a high-grade mitral valve insufficiency (III-IV) and paroxysmal atrial fibrillation.
Evaluation of a novel cryoablation system: in vitro testing of heat capacity and freezing temperatures. [2022]Cryoablation has been used to ablate cardiac tissue for decades and has been shown to be able to replace incisions in the surgical treatment of atrial fibrillation. This in vitro study evaluates the performance of a novel cryoprobe and compares it with existing commercially available devices.
Cardioblate surgical ablation system. [2009]Atrial fibrillation is the most common sustained arrhythmia and represents a considerable health burden. In recent years there has been an increased interest in ablation treatment of atrial fibrillation. The Cardioblate surgical ablation system offers a complete system for surgical ablation as a concomitant or lone atrial fibrillation procedure. Saline-irrigated radiofrequency energy is used to produce electrically isolating lines in the atrial tissue. A range of disposable devices can be connected to the generator. A comprehensive review of the devices and the results achieved with the system is given. The system is compared with other alternative energy sources and to the Cox-Maze procedure.
[Surgical treatment of atrial fibrillation]. [2006]Surgical treatment of atrial fibrillation becomes part of the complex therapy of this very frequent arrhythmia. It is based on the fragmentation of atria with formation of segments and channels, which prevent development of reentry phenomenon. Contemporary methods are aimed on the power of the left ventricle, namely on the pulmonary veins' orifice with the shift to less invasive techniques. At our clinic, method of linear cryoablation has been used for 26 patients (between May 2003 and October 2004). For the evaluation of results is the follow up period too short and the cohort too small, however, results are encouraging and worth of publication.
Evaluation of a novel cryoablation system: in vivo testing in a chronic porcine model. [2022]Cryoablation is commonly used at present in the surgical treatment of atrial fibrillation (AF). However, there have been few studies examining the efficacy of the commonly used ablation devices. This report compares the efficacy of two cryoprobes in creating transmural endocardial lesions on the beating heart in a porcine model for chronic AF.
Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. [2013]The development of ablative energy sources has simplified the surgical treatment of atrial fibrillation (AF) during concomitant cardiac procedures. We report our results using argon-based endocardial cryoablation for the treatment of AF in patients undergoing concomitant cardiac procedures.
The concomitant cryosurgical Cox-Maze procedure using Argon based cryoprobes: 12 month results. [2016]The cut and sew Cox-Maze III procedure has proven to be extremely effective in curing atrial fibrillation. Due to the relative complexity various procedures were developed to apply ablative lesions to treat atrial fibrillation using different energy sources. In this report we present data related to our experience with Argon based cryoablation system in patients having first time concomitant CryoCox-Maze III procedure and other cardiac surgical procedures.
CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation. [2020]Pulmonary vein (PV) isolation is the mainstay of catheter treatment of paroxysmal atrial fibrillation (AF). The CoolLoop® cryoablation catheter (AFreeze® GmbH; Innsbruck, Austria) was developed to create wide and complete circular lesions around the PVs. In this study we evaluated feasibility and safety of this novel ablation system in humans.