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N/A N=24 Prevention

Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors

TTR Cardiac Amyloidosis

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Sudden Death — 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Biotronik Biomonitor 3 implant of device (Device); Biotronik Biomonitor 3 explant of device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Mar 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Sudden Death
PRIMARY
Atrial Arrhythmias
10
PRIMARY
High Grade Atrioventricular (AV) Block
2
PRIMARY
Permanent Pacemaker Implantation
3

Summary

Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.

Eligibility Criteria

Inclusion Criteria

  • Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
  • Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
  • Patients aged 18 -85, both genders and of all races and ethnicities.
  • Patients must be competent to give informed consent.
  • Patients must be able to have the Biomonitor 3 implanted.
  • Amyloid stage I-III patients with existing implantable cardiac devices such as pacemakers or defibrillators

Exclusion Criteria

  • Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
  • Congenital heart disease.
  • Pregnant patients
  • Patients whose heart failure is felt to be secondary to primary valvular disease (>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
  • Absolute contraindications to cardiac MRI (such as renal failure with GFR<30%).
  • Unwilling or unable to provide informed consent.
  • Patients with other life threatening diseases that would likely decrease their life expectancy over the next four years.
  • Patients who are post cardiac transplant.
  • Difficulty to attend the follow-up schedule due to a history of medical noncompliance, difficulty, or unwillingness to return to the study center for follow up.
  • Evidence of ongoing bacteremia or sepsis preventing implantation of a device
  • Unwilling or able to have the Biomonitor 3 interrogated
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04421040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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