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A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery (SURGICAL-AF 2)

Primary Purpose

Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation and Flutter focused on measuring Atrial Fibrillation, Digital Health, Artificial Intelligence, Cardiac Surgery, Postoperative atrial fibrillation (POAF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
  • Subject provides informed consent
  • Subject understands and agrees to comply with planned study procedures.
  • Subject is able to perform heart rhythm measurement using the FibriCheck application at home.

Exclusion Criteria:

  • Pacemaker dependent heart rhythm
  • Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
  • Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
  • No smartphone available at home.

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rhythm monitoring group

Usual care

Arm Description

Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge.

Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge.

Outcomes

Primary Outcome Measures

Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
Any of the following therapeutic interventions: Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3) Cardioversion Cardiac implantable electronic device (CIED) implantation
Time to detection of a postoperative adverse event
Prespecified postoperative adverse events: 1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency 2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock 3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA) 4.1. Renal failure, defined as: >50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment 5. Wound related complications requiring surgical intervention or antibiotic treatment. 6. Sepsis 7. Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.

Secondary Outcome Measures

Time to primary endpoint (primary outcome 1)
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
Post-operative atrial fibrillation (POAF) detection rate
Time to POAF detection
POAF detection rate in subjects with an indication for anticoagulation
Detection rate of POAF lasting more than 6 hours
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
EQ-5D-5L is a EuroQol five-dimension scale questionnaire. The participant rates his or her own level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) from 1 to 5 and global health rating on a visual analogue scale (EQ-VAS) from 1 to 100.
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)

Full Information

First Posted
July 12, 2022
Last Updated
June 30, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05509517
Brief Title
A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery
Acronym
SURGICAL-AF 2
Official Title
Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.
Detailed Description
A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups: Subjects not on anticoagulation drug therapy (for a planned duration of >45 days) at discharge. Subjects with no history of AF prior to surgery and no POAF lasting >24h in hospital. Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF. additional risk factors include: chronic obstructive pulmonary disease sleep apnea impaired renal function left atrial enlargement elevated body mass index combined CABG with valve repair or replacement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications, Arrhythmia
Keywords
Atrial Fibrillation, Digital Health, Artificial Intelligence, Cardiac Surgery, Postoperative atrial fibrillation (POAF)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rhythm monitoring group
Arm Type
Experimental
Arm Description
Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge.
Intervention Type
Diagnostic Test
Intervention Name(s)
Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)
Intervention Description
Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).
Primary Outcome Measure Information:
Title
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
Description
Any of the following therapeutic interventions: Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3) Cardioversion Cardiac implantable electronic device (CIED) implantation
Time Frame
91 days
Title
Time to detection of a postoperative adverse event
Description
Prespecified postoperative adverse events: 1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency 2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock 3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA) 4.1. Renal failure, defined as: >50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment 5. Wound related complications requiring surgical intervention or antibiotic treatment. 6. Sepsis 7. Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.
Time Frame
91 days
Secondary Outcome Measure Information:
Title
Time to primary endpoint (primary outcome 1)
Time Frame
91 days
Title
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
Time Frame
91 days
Title
Post-operative atrial fibrillation (POAF) detection rate
Time Frame
91 days
Title
Time to POAF detection
Time Frame
91 days
Title
POAF detection rate in subjects with an indication for anticoagulation
Time Frame
91 days
Title
Detection rate of POAF lasting more than 6 hours
Time Frame
91 days
Title
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
Description
EQ-5D-5L is a EuroQol five-dimension scale questionnaire. The participant rates his or her own level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) from 1 to 5 and global health rating on a visual analogue scale (EQ-VAS) from 1 to 100.
Time Frame
91 days
Title
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
Description
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Time Frame
Two years
Title
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
Description
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve) Subject provides informed consent Subject understands and agrees to comply with planned study procedures. Subject is able to perform heart rhythm measurement using the FibriCheck application at home. Exclusion Criteria: Pacemaker dependent heart rhythm Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion Insufficient cognitive or comprehensive level of Dutch to participate to the trial. No smartphone available at home.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri Gruwez, MD
Phone
0032475223949
Email
henri.gruwez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Haemers, MD, PhD
Email
peter.haemers@uzleuven.be
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Gruwez, MD
Phone
003289212051
Email
henri.gruwez@gmail.com
First Name & Middle Initial & Last Name & Degree
Peter Hamers, MD, PhD
Email
peter.haemers@uzleuven.be

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery

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