Observational Study on Heart Procedures for Coronary Artery Disease and Atrial Fibrillation

This study, called the NEXUS Registry, is looking at how well certain heart procedures work for people with coronary artery disease or atrial fibrillation (Afib), a type of irregular heartbeat. Researchers are observing patients who undergo a hybrid procedure (ablation on the back of the heart), endocardial ablations (procedures inside the heart to block irregular heartbeats), or left atrial appendage occlusion (a procedure to prevent blood clots that can cause stroke). The study aims to understand how these procedures affect your quality of life and whether you need to be readmitted to the hospital. You can join if you are over 18, have coronary artery disease or Afib, and can attend follow-up appointments. The study is currently collecting information from patients.

Study design
This is an observational study that will follow 1000 participants over time. It is not a randomized trial.
What's involved
You will complete a disease-specific questionnaire. Your health information will be collected and analyzed over time.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 10 years, with check-ins at 6 months and then annually.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03428048

Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.

Recruiting
Not specifiedAges 18+Observational
Cardiovascular Innovation and Research Institute
~1,000 participants
Updated 2020-06-01 on ClinicalTrials.gov
What's tested:Hybrid procedureEndocardial ablationsleft atrial appendage occlusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Atrial Fibrillation Effect on Quality -of-Life (AFEQT) questionnaire at designated follow-up intervals
Measured over Initial Analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and then annually thereafter up to 10 years
+2 more outcomes measured
Coronary Artery Disease
Atrial Fibrillation (AF)
1 sites across 1 states
Colorado1
  • Frank A Laws, MD · PRINCIPAL_INVESTIGATOR · Valley View Hospital

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  • Change from baseline in Atrial Fibrillation Effect on Quality -of-Life (AFEQT) questionnaire at designated follow-up intervalsInitial Analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and then annually thereafter up to 10 years

    The AFEQT is a validated disease specific questionnaire used for assessing clinical disease impact on ADLs, emotional status, satisfaction with treatment and quality of life.

  • Change from baseline in Veterans Rand (VR) 12Initial analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and annually thereafter up to 10 years

    The VR 12 is a 12-item health survey, validated quality of life questionnaire- open source

  • Number of patients that experience a re-admit status post interventionWithin 90 days post intervention

    The number of patients that are re-admitted with a Serious Adverse Event (SAE) or Adverse Event (AE) as a result of their index procedure