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Oral Anticoagulation Therapy Pilot Study

NCT01959425 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-04

Study results available
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Summary

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

OTHER

Off OAT Group (Test)

Discontinuation of OAT Therapy

OTHER

On OAT Group (Control)

Continuation of OAT Therapy

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

  • Antonio Raviele, MD · Dell'Angelo Hospital

  • Michael Riley, MD · University of Pennsylvania

  • Karl Heinz Kuck, MD · Hanseatisches Herzzentrum, Asklepios Klinik

  • Michel Haissaguerre, MD · Hospital Cardiologigue du Haut-Leveque

  • Pierre Jais, MD · Hospital Cardiologigue du Haut-Leveque

  • Sakis Themistoclakis, MD · Dell'Angelo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-17
Primary Completion
2019-10-07
Completion
2019-10-07
FDA Drug
Yes

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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 NCT01959425 on ClinicalTrials.gov