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Procedure
Pacemaker Techniques for Atrial Fibrillation
N/A
Recruiting
Research Sponsored by Lawson Health Research Institute
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 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to compare the effectiveness of two different pacemaker techniques, BiVP and CSP, in patients with atrial fibrillation. These techniques are used in patients who undergo a procedure called AV node
Who is the study for?
This trial is for older adults with atrial fibrillation, a type of irregular heartbeat that can cause symptoms like skipped beats or shortness of breath. It's specifically for those who struggle to tolerate standard medications due to side effects and may benefit from a pacemaker combined with AV node ablation.
What is being tested?
The study compares two types of pacemakers: BiVP, which stimulates both sides of the heart, and CSP, a newer method with fewer leads. It also tests if these 'pace and ablate' strategies are better than just using drugs to manage heart rate in patients with AF.
What are the potential side effects?
Potential side effects include complications from implanting the pacemaker such as infection or bleeding, issues arising from damaging the AV node like abnormal heart rhythms, and typical medication-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Winratio
Secondary study objectives
All-cause hospitalization
All-cause mortality
Biochemical marker
+5 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: P&A-CSPExperimental Treatment1 Intervention
Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.
Group II: Pharmacological TherapyActive Control1 Intervention
Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
430,820 Total Patients Enrolled