Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03929718 |
Other study ID # |
AVOID-AF |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
April 24, 2019 |
Est. completion date |
September 2027 |
Study information
Verified date |
November 2023 |
Source |
Piedmont Healthcare |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to accurately determine, using an implantable rhythm monitor,
the long-term incidence of new atrial fibrillation after ablation of atrial flutter in those
treated with spironolactone compared with standard medical therapy.
Description:
Catheter ablation of the cavotricuspid isthmus (CTI) is an effective and safe procedure in
patients with atrial flutter (AFL) with excellent long-term results in preventing AFL
recurrences. However, new-onset atrial fibrillation (AF) commonly develops after this
procedure and has important clinical implications for patient management. Few studies have
assessed the long-term incidence and prevalence of AF after CTI ablation via intensive
continuous rhythm monitoring with an implantable cardiac monitor. Furthermore, whether the
development of AF can be impacted beneficially by adjunctive therapeutic approaches is not
known. The co-primary objectives of this pilot study in patients with typical atrial flutter
(AFL) but no previously detected AF are: 1) to accurately determine the long-term incidence
of new-onset AF after CTI ablation using an implantable rhythm monitor; 2) to compare the
rates of new onset AF in subjects randomized to standard, usual-care, medical therapy
following CTI ablation compared with those randomized to treatment with an aldosterone
antagonist (spironolactone) in addition to their usual care medications. The patient
population will be subjects with typical atrial flutter and a history of hypertension or
heart failure, but no known AF episodes, scheduled to undergo catheter ablation of the CTI
for treatment of AFL. Patients will be randomized to remain on their standard, usual-care.
medications or to take oral spironolactone (a standard, FDA-approved medication used in the
treatment of hypertension and heart failure) starting after their ablation procedure. The
primary study endpoint will be any atrial tachyarrhythmia episode (AF, AFL or atrial
tachycardia) lasting greater than one minute detected via the implanted cardiac monitor after
CTI ablation during long-term follow-up. The incidence of new-onset AF after CTI ablation
will be compared between subjects randomized to be treated with usual care vs. those treated
with usual care plus spironolactone on an intention to treat basis.