ArrythmiaNCT05032495
Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias
An observational study of Arrythmia, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arrythmia
- What is being tested?
- Surveys and Focus group
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 31 Aug 2023
- How long will I take part?
- 2 Years
- 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: Patients will be recruited from in house databases after confirming patients have agreed to participate in research.
Who may be able to join
- Upcoming or previous cardiac procedure.
Who cannot join
- Inability to complete an electronic survey or participate in a small group meeting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Directed Strategies for Cardiac Arrhythmia
In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.
Read the detailed description
There will be four study groups:
- Heart patients who experienced a cardiac arrhythmia while in hospital,
- Heart patients who did not experience a cardiac arrhythmia while in hospital,
- Heart patients with an upcoming procedure that have not had a cardiac arrhythmia,
- Members of the general public.
There will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.
- Conditions
- Arrythmia
- Being tested
- Surveys, Focus group
- Keywords
- Patient engagement
- Medical subject headings
- Arrhythmias, Cardiac, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Surveys to evaluate prior experience, opinions and intervention acceptability.
Focus groupOther
To answer any questions and discuss topics covered in the standard presentation.
| Study group | Role | What they receive |
|---|---|---|
| Heart patients who experienced a cardiac arrhythmia while in hospital | Heart patients who experienced a cardiac arrhythmia while in hospital Receives: Other: Surveys; Other: Focus group | |
| Heart patients who did not experience a cardiac arrhythmia while in hospital | Heart patients who did not experience a cardiac arrhythmia while in hospital Receives: Other: Surveys; Other: Focus group | |
| Heart patients with an upcoming procedure that have not had a cardiac arrhythmia | Heart patients with an upcoming procedure that have not had a cardiac arrhythmia Receives: Other: Surveys; Other: Focus group | |
| Members of the general public | Members of the general public Receives: Other: Surveys; Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey
accept a biological therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 May 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darryl Davis, Ottawa Heart Institute Research Corporation
- Investigators
- Darryl Davis, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032495
- Sponsor's protocol ID
- 3174
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Smith C, Lalu MM, Davis DR. Exploring Patient Viewpoints to Optimize Implementation of a Biological Therapy for Atrial Fibrillation Prevention. CJC Open. 2024 Apr 16;6(7):893-900. doi: 10.1016/j.cjco.2024.04.003. eCollection 2024 Jul.
PubMed 39026620
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Directed Strategies for Cardiac Arrhythmia
- ClinicalTrials.gov ID
- NCT05032495
- Acronym / sponsor ID
- 3174
- Conditions
- Arrythmia
- Keywords
- Patient engagement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 Sep 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.
In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.
Detailed description
There will be four study groups:
- Heart patients who experienced a cardiac arrhythmia while in hospital,
- Heart patients who did not experience a cardiac arrhythmia while in hospital,
- Heart patients with an upcoming procedure that have not had a cardiac arrhythmia,
- Members of the general public.
There will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heart patients who experienced a cardiac arrhythmia while in hospital | – | Other: Surveys, Other: Focus groupHeart patients who experienced a cardiac arrhythmia while in hospital |
| Heart patients who did not experience a cardiac arrhythmia while in hospital | – | Other: Surveys, Other: Focus groupHeart patients who did not experience a cardiac arrhythmia while in hospital |
| Heart patients with an upcoming procedure that have not had a cardiac arrhythmia | – | Other: Surveys, Other: Focus groupHeart patients with an upcoming procedure that have not had a cardiac arrhythmia |
| Members of the general public | – | Other: Surveys, Other: Focus groupMembers of the general public |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from in house databases after confirming patients have agreed to participate in research.
Key inclusion criteria (1 listed)
- Upcoming or previous cardiac procedure.
Key exclusion criteria (1 listed)
- Inability to complete an electronic survey or participate in a small group meeting.
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 |
|---|---|---|
| SurveysSurveys to evaluate prior experience, opinions and intervention acceptability. | Other | Heart patients who did not experience a cardiac arrhythmia while in hospital, Heart patients who experienced a cardiac arrhythmia while in hospital, Heart patients with an upcoming procedure that have not had a cardiac arrhythmia, Members of the general public |
| Focus groupTo answer any questions and discuss topics covered in the standard presentation. | Other | Heart patients who did not experience a cardiac arrhythmia while in hospital, Heart patients who experienced a cardiac arrhythmia while in hospital, Heart patients with an upcoming procedure that have not had a cardiac arrhythmia, Members of the general public |
Primary outcome
Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey
Time frame: 2 years
accept a biological therapy
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 9 Apr 2024.
- Derived from this study: PubMed 39026620Smith C, Lalu MM, Davis DR. Exploring Patient Viewpoints to Optimize Implementation of a Biological Therapy for Atrial Fibrillation Prevention. CJC Open. 2024 Apr 16;6(7):893-900. doi: 10.1016/j.cjco.2024.04.003. eCollection 2024 Jul.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
Darryl Davis principal investigator
Ottawa Heart Institute Research Corporation
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 Arrythmia, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 9 Apr 2024. 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 Canada. 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?
Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032495, which also lists 1 linked publication.
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 9 Apr 2024.