Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

NCT02156076

Paroxysmal Atrial Fibrillation

TERMINATED PHASE2

Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers

NCT00389792

Atrial Fibrillation

COMPLETED PHASE2

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

NCT07209852

Bradycardia Atrioventricular Block Sinus Node Dysfunction +1 more

RECRUITING

PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing

NCT00461734

Left Ventricular Dysfunction

COMPLETED NA

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

NCT00971204

Paroxysmal Atrial Fibrillation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Tablets, Oral, 10 mg, Every Day (QD), 20 days

Intervention Type DRUG

BMS-914392

Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days

Intervention Type DRUG

BMS-914392

Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days

Intervention Type DRUG

Placebo

Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Paroxysmal atrial fibrillation (AF)
* Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
* 1-50% AF burden on pacemaker interrogation at screening.
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.

Exclusion Criteria

* Persistent or permanent AF.
* AF Burden \<1% or \> 50%.
* Current or history of neurological diseases and mental disorders.
* Ejection Fraction \< 45%.
* Severe mitral or aortic valve dysfunction.
* TIA (Transient Ischemic Attack) within last 12 months.
* Acute coronary syndrome in the last 2 months.
* Previous AF ablation.
* Cardioversion in last 3 months.
* Current kidney or liver disease, or current cancer.
* History of neurological and mental disorders.
* Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
* Screening lab test results outside of allowed limits per protocol.
* QTcF \> 450 msec.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No