Completed

Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LAA occluder

+ RFA ablation

+ Warfarin

DeviceProcedureDrug
Who is being recruted

Arrhythmias, Cardiac+3

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2011
See protocol details

Summary

Principal SponsorMeshalkin Research Institute of Pathology of Circulation
Last updated: July 8, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2011

Actual date on which the first participant was enrolled.

The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.

NCT01695824
Principal SponsorMeshalkin Research Institute of Pathology of Circulation
Last updated: July 8, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtrial Fibrillation

Criteria

3 inclusion criteria required to participate
CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])
Eligible for long term warfarin
Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
7 exclusion criteria prevent from participating
Atrial septal or Patent Foramen Ovale (PFO) device
CHF Class 4
Contraindicated for aspirin or clopidogrel (Plavix)
Contraindicated for warfarin
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

State Research Institute of CIrculation Pathology

Novosibirsk, RussiaOpen State Research Institute of CIrculation Pathology in Google Maps
CompletedOne Study Center