Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-05 @ 2:54 PM
Study NCT ID:
NCT00611260
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2008-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.
We wish to test the following hypotheses:
1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
2. Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).
We wish to test the following hypotheses:
1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
2. Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).
Detailed Description:
This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: