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Procedure
Ablation for Atrial Flutter
N/A
Recruiting
Led By Aneesh Tolat, MD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at one month after ablation
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the safety, feasibility, and efficacy of performing atrial flutter ablation through the arm vs. the standard femoral vein approach. #MedicalStudy #AtrialFlutter
Who is the study for?
This trial is for outpatients weighing at least 50 kg with documented typical atrial flutter, referred for right atrial flutter ablation. It's not open to inpatients, those unable to consent, individuals under 50 kg, or patients with a pacemaker or defibrillator with transvenous leads.
What is being tested?
The study tests the safety and effectiveness of performing atrial flutter ablation through the arm instead of the femoral vein. It compares recovery time, success rates of maintaining sinus rhythm without recurrence, complication rates including bleeding and heart issues, and pain severity at insertion sites between both methods.
What are the potential side effects?
Potential side effects include complications from accessing veins such as bleeding or thrombosis (clotting), heart perforation during the procedure, discomfort at the site where catheters are inserted into the body (either arm or groin), and possible failure to maintain normal heart rhythm post-procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at one month after ablation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at one month after ablation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recovery time
Secondary study objectives
Complication rate
Frequency of complications
One month success rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ablation through upper extremityExperimental Treatment1 Intervention
Ablation through arm
Group II: Ablation through femoral veinActive Control1 Intervention
Ablation through vein
Find a Location
Who is running the clinical trial?
Hartford HospitalLead Sponsor
139 Previous Clinical Trials
19,653 Total Patients Enrolled
Aneesh Tolat, MDPrincipal InvestigatorHartford Hospital
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently admitted to a hospital.You have a pacemaker or defibrillator with certain types of leads.I am scheduled for a procedure to correct heart flutter as an outpatient.You have a specific heart rhythm problem called atrial flutter, which has been confirmed by a heart test called EKG or telemetry.I weigh at least 110 pounds.My body weight is under 50 Kg.I am unable to give consent by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Ablation through upper extremity
- Group 2: Ablation through femoral vein
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.