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Device
Surgical Ablation for Atrial Fibrillation
N/A
Recruiting
Led By Ralph J Damiano, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of non-paroxysmal AF (persistent or longstanding persistent)
Valve repair or replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months post-procedure to 12-months post-procedure
Awards & highlights
Study Summary
This trial is testing a new device to treat non-paroxysmal AF (a type of irregular heartbeat). They want to show that it is safe and effective.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include bleeding due to anticoagulants required post-surgery, risks associated with heart surgery such as infection or complications from the device use itself which could affect heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a long-term irregular heartbeat that doesn’t stop on its own.
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I have had a valve repair or replacement surgery.
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I need a planned open-heart surgery.
Select...
I need a planned open-heart surgery, like bypass or valve repair.
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I can take warfarin or other new oral blood thinners.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months post-procedure to 12-months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months post-procedure to 12-months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite acute major adverse event rate
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Secondary outcome measures
AFEQT Quality of Life Score over time (Efficacy)
Acute procedural success (Efficacy)
Composite acute major adverse event rate (Safety)
+5 moreTrial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Ablation
2007
N/A
~120
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,172 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
176 Patients Enrolled for Atrial Fibrillation
Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
9,463 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
75 Patients Enrolled for Atrial Fibrillation
Ralph J Damiano, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
47 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
47 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term irregular heartbeat that doesn’t stop on its own.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.I have had a valve repair or replacement surgery.I need a planned open-heart surgery.I need urgent heart surgery or a repeat open heart surgery.I need a planned open-heart surgery, like bypass or valve repair.I have Wolff-Parkinson-White syndrome.I am on dialysis for kidney failure or have liver failure.You are expected to live for less than 1 year.I have an ongoing heart infection.Your left atrial diameter is bigger than 6.0 cm.I have had a procedure to correct my irregular heartbeat.You are currently taking part in a study for a new medicine or device to treat atrial arrhythmias, or you plan to join one.I can take warfarin or other new oral blood thinners.Your chance of dying from surgery is estimated to be more than 10% based on a special calculator.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.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants for this investigation?
"Affirmative. Clinicaltrials.gov's records show that this medical trial, first published in November 2018, is actively enrolling patients. The total number of participants needed for the study comes to 160 and they will be recruited from 14 different sites."
Answered by AI
What effects are the researchers hoping to discern from this clinical trial?
"This medical trial, evaluated for a period ranging from 6 months to 12 months after the procedure, is aimed at assessing the Composite acute major adverse event rate. Secondary objectives encompass Freedom from AF/AFL/AT over 12-months post-procedure (Efficacy), Acute procedural success (Efficacy) and Percentage of new permanent pacemaker implantation (Safety)."
Answered by AI
How many medical facilities are presently participating in this experiment?
"This research study is welcoming patients at Hartford Healthcare in Connecticut, Spectrum Health Hospitals in Michigan, Allegheny General Hospital in Pennsylvania and 14 additional medical centres."
Answered by AI
Are there current opportunities to participate in this research project?
"Affirmative. Clinicaltrials.gov's records confirm that this investigation is presently seeking participants, which was initially posted on November 15th 2018 and updated October 17th 2022. 160 individuals are expected to be recruited from 14 trial sites."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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