Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation

Launched by UNIVERSITY OF ROCHESTER · Jun 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with atrial fibrillation (AF) manage their condition after a specific heart procedure called catheter ablation. The goal is to see if using an insertable cardiac monitor can help reduce the frequency and severity of AF episodes in people who have had either persistent or occasional AF. This monitor is a small device that can be placed under the skin to track heart rhythms, allowing doctors to better understand how well the treatment is working.

To participate in the trial, you need to be 18 years or older and have a history of either occasional AF that lasts less than a week or persistent AF that has lasted more than a week but less than three years. You should be scheduled to undergo catheter ablation for AF within two months of agreeing to join the study. If you decide to take part, you can expect to have the monitor placed shortly after your procedure, and your progress will be closely followed by healthcare professionals. It’s important to know that this trial is currently recruiting participants, and they are looking for people of all genders who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • History of paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days), according to current guideline indications for paroxysmal AF CA (Class I/II); or patients with history of persistent atrial fibrillation (per 2019 HRS guidelines definition: sustained AF episode lasting more than 7 days, but less than 3 years), according to current guideline indications for persistent AF CA (Class I/IIIa) any time in the past.
• • 18 years of age or older at time of consent
• • CA to be performed for AF as standard of care within 2 calendar months after consent and prior to randomization date
• * One of the following:
• • Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 2 calendar months after consent and prior to randomization date
• • Patients with an existing CIED (ICD/CRTD/PPM/ICM) are allowed if there is an atrial lead to track AF.
• • Patient without an existing CIED preferring to use a noninvasive LT-ECG monitor.
• • Exclusion criteria
• • Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA)
• • Inability to tolerate any AAD therapy
• • Permanent atrial fibrillation lasting more than 3 years prior to date of consent
• • NYHA class IV congestive heart failure
• • Life expectancy \<1 year after consent date for any medical condition
• • Pregnancy or nursing
• • Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent
• • Participation in other interventional research studies (observational registries are allowed).