Atrial FibrillationNCT06155357
A Study of a Lifestyle Program on Recurrent Atrial Fibrillation
A study testing Multicomponent lifestyle intervention program in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Multicomponent lifestyle intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Aug 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal or persistent atrial fibrillation.
- Planned elective catheter ablation of AF.
Who cannot join
- Prior catheter ablation.
- Presence of pacemaker/ICD.
- Longstanding persistent AF.
- Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation
The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.
- Conditions
- Atrial Fibrillation
- Being tested
- Multicomponent lifestyle intervention program
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent lifestyle intervention programBehavioural
The multicomponent lifestyle intervention program is targeted at risk factor management, increased exercise capacity, and weight loss. The program will commence upon order/referral for ablation. Ablation would occur during the lifestyle program and the program will be continued after the ablation to complete 12 weeks or up to 36 exercise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Interventions Pre-Procedure | Experimental | Subjects with paroxysmal or persistent atrial fibrillation (AF) who are scheduled to undergo elective catheter ablation of AF will participate in a 12-week multicomponent lifestyle intervention program. Receives: Behavioral: Multicomponent lifestyle intervention program |
| Standard of Care | No intervention | Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cardiac Rehab Sessions Attended
Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.
Measured: 12 weeks
Secondary outcomes (4)
Number of subjects with Atrial Fibrillation (AF) recurrence
Number of subjects with AF recurrence will be assessed by chart review and clinically indicated holter monitor.
Measured: 1 year
Change in weight loss
Change in weight loss pre \& post multicomponent lifestyle intervention program reported in kilograms (kg)
Measured: Baseline, 12 weeks
Change in exercise capacity
Change in exercise capacity will be assessed by 6-minute walk test pre \& post multicomponent lifestyle intervention program. Measurement (meters) of distance a person can walk on flat ground in 6 minutes.
Measured: Baseline, 12 weeks
Change in Atrial Fibrillation (AF) Symptom severity
Change in AF Symptom Severity will be assessed by the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS questionnaire is a 19-item self-administered questionnaire developed to capture subjective and objective ratings of AF related symptoms, health care utilization, and AF disease burden, including frequency, duration, and severity of episodes. Higher scores indicate higher symptom severity (range of 0-35).
Measured: Baseline, 12 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda R. Bonikowske, Mayo Clinic
- Investigators
- Amanda Bonikowske, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155357
- Sponsor's protocol ID
- 23-003042
- Status last verified
- Dec 2024
- First submitted
- 24 Nov 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06155357
- Acronym / sponsor ID
- 23-003042
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Dec 2023 (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.
The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Interventions Pre-Procedure | Experimental | Behavioral: Multicomponent lifestyle intervention programSubjects with paroxysmal or persistent atrial fibrillation (AF) who are scheduled to undergo elective catheter ablation of AF will participate in a 12-week multicomponent lifestyle intervention program. |
| Standard of Care | No intervention | –Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paroxysmal or persistent atrial fibrillation.
- Planned elective catheter ablation of AF.
Key exclusion criteria (4 listed)
- Prior catheter ablation.
- Presence of pacemaker/ICD.
- Longstanding persistent AF.
- Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
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 |
|---|---|---|
| Multicomponent lifestyle intervention programThe multicomponent lifestyle intervention program is targeted at risk factor management, increased exercise capacity, and weight loss. The program will commence upon order/referral for ablation. Ablation would occur during the lifestyle program and the program will be continued after the ablation to complete 12 weeks or up to 36 exercise sessions. | Behavioural | Lifestyle Interventions Pre-Procedure |
Primary outcome
Number of Cardiac Rehab Sessions Attended
Time frame: 12 weeks
Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.
4 secondary outcomes
Number of subjects with Atrial Fibrillation (AF) recurrence
Time frame: 1 year
Change in weight loss
Time frame: Baseline, 12 weeks
Change in exercise capacity
Time frame: Baseline, 12 weeks
Change in Atrial Fibrillation (AF) Symptom severity
Time frame: Baseline, 12 weeks, 6 months, 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Amanda Bonikowske principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent lifestyle intervention program in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 4 Dec 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 Cardiac Rehab Sessions Attended (time frame: 12 weeks). 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 4 Dec 2024.