SMART Program for Paroxysmal Atrial Fibrillation

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation, Stress

In brief

This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on quality of life, mental health, arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial fibrillation (PAF).

Key facts

Study ID

NCT03450993

Run by

Massachusetts General Hospital

People needed

18

Starts

2018-02-23

Expected to finish

2019-01-04

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with documented recurrent symptomatic PAF.
• Currently on stable medical therapy for AF and willing to continue on the same treatment regimen while participating in the study.
• No current daily practice of yoga, meditation, guided imagery or other techniques that elicit the RR.
• Able to provide informed consent and to understand written and spoken English.

You may not qualify if…

• Allergy to adhesives that prevents wearing the HRV monitor.
• Patients unable or unwilling to participate in an intervention delivered via video conferencing.
• End Stage renal failure or heart failure, severe unstable medical or psychiatric disease.
• Patients deemed unable to complete protocol due to cognitive or other reasons.
• Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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