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Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05032495
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Darryl Davis, Ottawa Heart Institute Research Corporation

Brief 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. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.

Condition or disease Intervention/treatment
Arrythmia Other: Surveys Other: Focus group

Detailed Description:

There will be four study groups:

  1. Heart patients who experienced a cardiac arrhythmia while in hospital,
  2. Heart patients who did not experience a cardiac arrhythmia while in hospital,
  3. Heart patients with an upcoming procedure that have not had a cardiac arrhythmia,
  4. Members of the general public.

There will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Patient Directed Strategies for Cardiac Arrhythmia
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Heart patients who experienced a cardiac arrhythmia while in hospital
Heart patients who experienced a cardiac arrhythmia while in hospital
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.

Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.

Heart patients who did not experience a cardiac arrhythmia while in hospital
Heart patients who did not experience a cardiac arrhythmia while in hospital
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.

Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.

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
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.

Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.

Members of the general public
Members of the general public
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.

Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from in house databases after confirming patients have agreed to participate in research.
Criteria

Inclusion criteria:

  • Upcoming or previous cardiac procedure.

Exclusion Criteria:

  • Inability to complete an electronic survey or participate in a small group meeting.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032495


Contacts
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Contact: Darryl Davis, MD 613-696-7298 ddavis@ottawaheart.ca
Contact: Sarah Beaudoin 613-696-7298 SBeaudoin@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Insitute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Darryl Davis         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Darryl Davis Ottawa Heart Institute Research Corporation
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Responsible Party: Darryl Davis, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05032495    
Other Study ID Numbers: 3174
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darryl Davis, Ottawa Heart Institute Research Corporation:
Patient engagement
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes