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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & 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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