Cardiac ArrhythmiaNCT04957108
Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application.
An observational study of Cardiac Arrhythmia, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Device identification using Xray.
- How many people
- 547 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients undergoing CIED implantation and having post-device Xray were included.
Who may be able to join
- All patients undergoing CIED implantation and having xray post-implant at any point and time.
Who cannot join
- Patients with CIED for whome Xray was not available.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application in Identifying Cardiac Implantable Electronic Device Manufacturer Using Chest Radiograph - an Observational Study.
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.
Read the detailed description
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.
547 patients who underwent CIED implantation from year 2016 - 2020 in our institute were enrolled. There were 438 Medtronic and 109 St. Jude's devices. All chest radiographs were de-identified and resized into 225*225 pixels focusing on the CIED. PMIDa and CRMD-f applications were used to identify CIED. Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Device identification using Xray.
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device identification using Xray.Other
PMIDa and CRMD-f applications were used to identify CIED
| Study group | Role | What they receive |
|---|---|---|
| All cardiac implantable devices | Assessed separately by Pacemaker ID app and cardia-x algorithm Receives: Other: Device identification using Xray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. Above mentioned values shall be calculated after analysing data in SPSS and doing cross tabulation. Values will be in percentages.
Measured: Upto 6 months of enrollment
Secondary outcomes (1)
sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. Above mentioned values shall be calculated after analysing data in SPSS and doing cross tabulation. Values will be in percentages.
Measured: Upto 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirbhat Shams, Aga Khan University Hospital, Pakistan
- Investigators
- Yawer Saeed, MBBS, PHD, Principal investigator, The Aga Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957108
- Sponsor's protocol ID
- 2020-5101-14156
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application in Identifying Cardiac Implantable Electronic Device Manufacturer Using Chest Radiograph - an Observational Study.
- ClinicalTrials.gov ID
- NCT04957108
- Acronym / sponsor ID
- 2020-5101-14156
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.
Detailed description
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.
547 patients who underwent CIED implantation from year 2016 - 2020 in our institute were enrolled. There were 438 Medtronic and 109 St. Jude's devices. All chest radiographs were de-identified and resized into 225*225 pixels focusing on the CIED. PMIDa and CRMD-f applications were used to identify CIED. Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All cardiac implantable devices | – | Other: Device identification using Xray.Assessed separately by Pacemaker ID app and cardia-x algorithm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing CIED implantation and having post-device Xray were included.
Key inclusion criteria (1 listed)
- All patients undergoing CIED implantation and having xray post-implant at any point and time.
Key exclusion criteria (1 listed)
- Patients with CIED for whome Xray was not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device identification using Xray.PMIDa and CRMD-f applications were used to identify CIED | Other | All cardiac implantable devices |
Primary outcome
Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
Time frame: Upto 6 months of enrollment
Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. Above mentioned values shall be calculated after analysing data in SPSS and doing cross tabulation. Values will be in percentages.
1 secondary outcome
sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
Time frame: Upto 6 months of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yawer Saeed, MBBS, PHD principal investigator
The Aga Khan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. (time frame: Upto 6 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.