Recruiting

Observational Study

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT01816308

Conditions

Atrial Fibrillation

Mild Cognitive Impairment

Dementia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study aims to compare the incidence of new-onset cognitive impairments and change in existing impairment status between AF patients undergoing either catheter ablation or remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).

Conditions

Atrial Fibrillation

Mild Cognitive Impairment

Dementia

Study ID

NCT01816308

Start date

Jul, 2014

Status verified date

Sep, 2019

Completion date

Dec, 2022

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age: ≥ 50 years, male or female subjects
2. Clinical diagnosis of AF
3. Ability to provide written, informed consent

Exclusion Criteria:

1. Patients with established dementia
2. MoCA score ≤ 17 on Montreal Cognitive Assessment (MoCA)
3. Use of illicit drugs
4. Alcohol use: >12 drinks/week on average
5. Clinical evidence of delirium or altered mental status
6. Medically unstable patients (acute/unstable or poorly controlled problems that would demand focused, relatively urgent or emergent medical attention)

Study Design

Enrollment

888 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Mitra Mohanty, MD

512-544-8198mitra.mohanty@stdavids.com

Locations

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Mitra Mohanty, MD

512-544-8198mitra.mohanty@stdavids.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Sep 9, 2019

Last verified

Sep, 2019

Keywords

  • AF
  • MCI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2019-09-09.