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Post-Ablation Pericarditis Reduction Study (PAPERS)

NCT06731595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-12-12

No results posted yet for this study

Summary

There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to

1. Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).
2. Identify potential differences in patients undergoing PVI only versus PVI + additional ablation
3. Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without
4. Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF

Conditions

Interventions

DRUG

Colchicine

colchicine 0.6mg oral twice daily for 7 days

Sponsors & Collaborators

  • Asenson Sacred Heart - Pensacoloa, FL

    collaborator UNKNOWN

  • St. Vincent Cardiovascular Research Institute

    lead OTHER

Principal Investigators

  • Parin J. Patel, MD · Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2022-01-30
Completion
2022-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731595 on ClinicalTrials.gov