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Search / Trial NCT06431828

Remote Symptom Review in Patients With Implantable Diagnostic Holter

Launched by ANDRES IÑIGUEZ ROMO · May 21, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Implantable Loop Recorder Arrythmia Atrial Fibrillation Home Monitoring

ClinConnect Summary

This clinical trial is looking at a new way to monitor patients with certain heart conditions, like atrial fibrillation (an irregular heartbeat) and fainting spells. It involves using a special device called the BIOMONITOR III, which continuously tracks your heart activity and sends alerts to healthcare providers. Patients will also use a smartphone app to report any symptoms they experience. The goal is to see if this remote monitoring method helps doctors respond better and improve patient care compared to traditional hospital monitoring methods.

To participate in the trial, you need to be at least 18 years old and have been recommended for the implantable device because of fainting or unexplained strokes. You also need to be comfortable using the app to share your symptoms. The trial is open to all adults but not to anyone over 80 who may struggle to use the app. If you join, you’ll be closely monitored and can contribute to improving heart health care for others in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection)
  • Patients over 18 years old.
  • Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms.
  • Patients capable of using the patient application.
  • Exclusion Criteria:
  • Patients over 80 years of age or, failing that, not able to use an application to send their symptoms.
  • Life expectancy of less than 12 months for any reason.

About Andres Iñiguez Romo

Andres Iñiguez Romo is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization collaborates with healthcare professionals and research institutions to design and execute rigorous clinical studies across various therapeutic areas. By prioritizing safety, ethical standards, and scientific integrity, Andres Iñiguez Romo aims to contribute valuable insights to the medical community and facilitate the development of effective treatments that address unmet clinical needs.

Locations

Vigo, , Spain

Patients applied

0 patients applied

Trial Officials

Andrés Iñiguez Romo, MD, phD

Study Chair

Servicio Galego de Saude

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported