Recruiting

Atrial Fibrillation

Sponsor:

Happitech BV

Code:

NCT07779213

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

12 Lead ECG is compared to a smartphone based PPG

Study Details

Brief summary:

The protocol is designed to enroll patients from at least 3 diverse clinical sites with smartphones who are being evaluated for the presence or absence of atrial fibrillation (AF) using the Heart Rhythm Software algorithm running on their smartphones. Algorithm output will be compared to a gold standard of 12-lead ECG recorded with a simultaneous PPG measurement.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT07779213

Start date

Jun 30, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults aged 22 years or older
2. Owns a smartphone and knows how to operate and navigate different applications.
3. Individuals able to read, understand, and sign the consent form.
4. Cardiology patients consulting the cardiac outpatient clinic.
5. History of persistent AF or other cardiac rhythm

Exclusion Criteria:

1. Participants with cognitive impairments
2. Individuals who cannot read, speak, and/or understand English
3. Patients with implantable neurostimulators, cardiac implantable device in an atrial or ventricular paced rhythm documented on a 12-lead ECG during the initial study visit

Study Design

Enrollment

554 participants

Anticipated

Interventions and Outcome Measures

Arms

Sinus Rhythm

Patient visiting the Cardiology Clinic in Sinus Rhythm

Atrial Fibrillation

Patient visiting the Cardiology Clinic in Atrial Fibrillation

Other

Patient visiting the Cardiology Clinic with neither Sinus Rhythm or Atrial Fibrillation

Interventions

12 Lead ECG is compared to a smartphone based PPG

12 Lead ECG is compared to a smartphone based PPG

Primary outcome measure

  • To evaluate the sensitivity and specificity of the Heart Rhythm Software [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Yosef Safi Harb, CEO

+31 (0) 681885565yosef@happitech.com

Amanda Marinov, Regulatory

+359878422979a.marinov@happitech.com

Locations

Nair Research, LLC dba Arrhythmia Research Group LLC

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Kayla Rubino

870-340-7387krubino@drnairresearch.com

Principal Investigator:

Devi Nair, Doctor

South Denver Cardiology

Recruiting

Littleton, Colorado, United States, 80210

Contacts

Kathy Siegel, Clinical Research Director

720-217-6139ksiegel@southdenver.com

Principal Investigator:

Srikanth Sundaram, Doctor

CardioVascular Health Clinic

Recruiting

Oklahoma City, Oklahoma, United States, 73134

Contacts

Sophie Haynes, Regulatory Director

405-696-0007sophie@hightowerclinical.com

Principal Investigator:

Monica Lo, Doctor

More Information

Sponsor

Happitech BV

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • wearables
  • smartphone based ppg
  • ppg
  • digital health
  • health equity
  • atrial fibrillation
  • healthtech
  • cardiac monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Happitech BV on 2026-08-21.