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iHEART for Atrial Fibrillation (iHEART Trial)

N/A
Waitlist Available
Led By Suzanne Bakken, PhD, RN
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

iHEART Trial Summary

Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.

Eligible Conditions
  • Atrial Fibrillation
  • Atrial Flutter

iHEART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in treatment outcomes initiated by recurrence
Rate of recurrence of atrial arrhythmias
Secondary outcome measures
Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores between Baseline and Six Months Chronic Cardiovascular Conditions
Difference in Mean Quality-Adjusted Life-Years between Groups

iHEART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: iHEARTExperimental Treatment2 Interventions
Participants will transmit daily ECGs using AliveCor for 6 months following cardioversion or ablation procedure to treat AF/AFL. Participants will also receive read-only behavioral altering messaging three times per week focusing on AF, cardiovascular risk factors, and healthy living.
Group II: Usual CareActive Control1 Intervention
Participants will continue with usual care with their physician.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,569 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
75 Patients Enrolled for Atrial Fibrillation
Suzanne Bakken, PhD, RNPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~26 spots leftby Apr 2025