Trial Information
Current as of May 13, 2025
Unknown status
Keywords
ClinConnect Summary
Atrial tachyarrhythmias (ATA) and heart failure (HF), which are well-recognized causes of morbidity and mortality, are growing and concerning issues in our patient population. In patients implanted with a dual-chamber implantable cardioverter defibrillator (ICD), progression of paroxysmal to persistent or permanent atrial fibrillation (AF) has been documented. Because of the untoward consequences of AF, such as development/worsening of HF or thromboembolic events (stroke and myocardial infarction \[MI\]), prevention of permanent AF has the potential to improve quality of life, reduce hospit...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • male and female patients
- • ≥18 years old (no upper age limit)
- • previously implanted with a Medtronic dual-chamber or CRT ICD with capability of atrial antitachycardia pacing; specifically, Reactive ATP™ at least 9 months previously (six months data collection and implant occurring at least 3 months previously to allow healing and establishment of stable sensing)
- • measured P wave in sinus rhythm of at least 0.8 mV
- • \>=6 months AT/AF burden data available, either from CareLink® or in-office interrogation
- • \>=1.0% AT/AF burden (hours in atrial fibrillation/total hours monitored) in the last 6 months
- • No change in antiarrhythmic drug therapy (Vaughan-Williams class I or III) in the last 6 months
- Exclusion Criteria:
- • Persistent or permanent AT/AF (AF burden \>95%)
- • Cardioversion for atrial fibrillation or atrial flutter within the last 6 months, either intentional or as a result of a tachyarrhythmia therapy
- • Ablation for atrial fibrillation or atrial flutter within the last 9 months (6 months data collection following a 3 month blanking period post procedure)
- • Reactive ATP™ previously programmed on
- • Measured P waves in sinus rhythm consistently \<0.8 mV on repeat measurements.
- • Unresolved artifactual AT/AF detection due to far-field R wave or other oversensing
- • Expected generator change or other device surgery within six months
About Hartford Hospital
Hartford Hospital is a leading academic medical center affiliated with the University of Connecticut, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical research, the hospital focuses on a diverse range of therapeutic areas, aiming to improve patient outcomes and enhance treatment methodologies. With a robust infrastructure and a multidisciplinary team of experts, Hartford Hospital fosters a collaborative environment that supports the development and implementation of cutting-edge medical interventions, ultimately contributing to the advancement of medical science and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hartford, Connecticut, United States
Patients applied
Trial Officials
Steven Zweibel, MD
Principal Investigator
Hartford HealthCare
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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