PVI, non-PV triggers & CS-LA connection for Atrial Fibrillation (PRECAF Trial)

N/A

Waitlist Available

Led By Saman Nazarian, M.D., Ph.D

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Patients with paroxysmal or persistent atrial fibrillation; AND Undergoing first AF ablation; AND Age ≥ 18 years.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time to af recurrence will be recorded as time to the first ecg or monitor that shows af recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180 days post ablation).

Awards & highlights

No Placebo-Only Group

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom control for many patients worldwide. However, long-term success rates remain suboptimal. Prior work indicates that distal connections between coronary sinus musculature and the left atrium exist and provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this trial, the investigators will examine the efficacy of elimination of distal connection(s) between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias.

Eligible Conditions

Atrial Fibrillation
Arrhythmia
Cardiac Arrhythmias

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time to af recurrence will be recorded as time to the first ecg or monitor that shows af recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180 days post ablation).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time to af recurrence will be recorded as time to the first ecg or monitor that shows af recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180 days post ablation).

This trial's timeline: 3 weeks for screening, Varies for treatment, and time to af recurrence will be recorded as time to the first ecg or monitor that shows af recurrence between the end of the blanking period (90 days post ablation) and the end of the study (180 days post ablation). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to recurrence of atrial arrhythmias

Secondary study objectives

Atrial fibrillation burden

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: PVI, non-PV triggers & CS-LA connectionActive Control2 Interventions

Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation in addition to coronary sinus-left atrium connection elimination. Distal coronary sinus pacing will be utilized to localize the earliest connection (aside from septal) from the coronary sinus to the left atrial musculature. Once localized, focal radiofrequency lesions will be applied at the discretion of the investigator until distal coronary sinus to left atrial connections are eliminated.

Group II: PVI, non-PV triggersActive Control1 Intervention

Interventions: Atrial fibrillation ablation, including conventional pulmonary vein isolation (PVI) and non-PV triggers ablation.

0 / 1Eligibility criteria met