Atrial FibrillationPACE-AFNCT06377046
Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial
A study testing Accelerated pacing in people with Atrial Fibrillation and Permanent Atrial Fibrillation, run by Maastricht University Medical Center.
Trial summary
The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Permanent Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Accelerated pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 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
- Adults > 18 years of age
- Referred for pace-and-ablate strategy with LBBAP for symptomatic AF
- Left ventricular ejection fraction ≥ 40%.
- Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent.
Who cannot join
- Infiltrative or constrictive cardiomyopathy (cardiac amyloidosis/sarcoidosis/ constrictive pericarditis)
- Severe Valvular heart disease (more than moderate valvular stenosis or regurgitation, aortic or mitral valve replacement)
- Patient participating in another interventional clinical trial
- Recent (< 3 months) Myocardial infarction (MI), Transient Ischemic Attack or Cerebro- Vascular Accident
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accelerated PACing for Improved Quality of lifE in Symptomatic Atrial Fibrillation Patients Undergoing Pace-and-ablate Strategy With Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF
The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.
The main question it aims to answer is:
Read more
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.
Secondary questions it aims to answer are:
- To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.
- To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:
- NT pro BNP levels
- device detected atrial fibrillation burden and daily activity
- echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain
Read the detailed description
Rationale:
Permanent pacemaker implantation combined with atrioventricular node ablation (AVNA) reduces symptoms and improves health-related quality of life (HRQoL) in patients with symptomatic atrial fibrillation (AF). A high percentage of conventional right ventricular pacing increases the risk for pacing-induced cardiomyopathy, a risk which is presumably minimised by a form of conduction system pacing, termed left bundle branch area pacing (LBBAP). LBBAP attempts to recreate the normal physiologic activation of the heart through stimulation of the heart's own natural conduction system, thereby maintaining ventricular synchrony. This strategy may be particularly important in patients with heart failure with preserved ejection fraction (HFpEF), a diagnosis that frequently coexists with AF. The long-term programming of a patient undergoing a "pace-and-ablate strategy" (pacemaker implantation and AVNA), is such that the lower rate of the pacemaker is routinely set to 60 bpm. Previous studies have shown that accelerated pacing (ie. programming the pacemaker to a lower rate of 80bpm) may improve HRQoL in a subset of patients with HFpEF. It is therefore hypothesized that accelerated pacing will improve HRQoL in patients with symptomatic AF undergoing a pace and ablate strategy, when compared to pacing at 60 bpm, which is standard of care.
Objective:
Primary objective: To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
Secondary objectives:
- To study, in a subset of participants who give informed consent, the acute hemodynamic effect of accelerated pacing rates on pulmonary capillary wedge pressure (PCWP), cardiac output and arterial blood pressure, among AF patients undergoing a pace-and-ablate strategy with LBBAP.
- To study the long-term (6 months) effects of accelerated pacing among AF patients undergoing a pace-and-ablate strategy with LBBAP by measuring NT-proBNP levels, device detected AF-burden and daily activity, by evaluating HRQoL questionnaires (SF-36), and by assessing echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end-diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain) compared to pacing at the standard of care lower rate of 60bpm.
- To investigate whether participants experience symptoms of accelerated pacing (such as palpitations), based on the Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire, compared to standard of care.
Study design:
Randomized, single center, prospective, single blinded, parallel group, pilot-trial.
Study population:
Patients ≥ 18 years with symptomatic AF undergoing pace-and-ablate strategy.
Intervention:
- 1:1 randomization to a lower rate of DDDR 80 bpm (intervention) or a lower rate of DDDR 60 bpm (control). Duration of the study is 6 months.
In a subset of participants:
- Right heart catheterisation and invasive blood pressure measurements will be conducted to evaluate acute hemodynamic effects of different (accelerated) ventricular pacing rates during the standard of care AV node ablation.
Main study parameters/endpoints:
Primary endpoint:
Difference in HRQoL between a lower rate of 80 bpm and a lower rate of 60 bpm, based on the Minnesota Living with Heart Failure Questionnaire (MLHFQ), determined at 6 months follow-up.
Secondary endpoints:
- The acute hemodynamic effects of (accelerated) pacing at time of AVNA:
- Pulmonary Capillary Wedge Pressure (PCWP)
- Cardiac Output (CO)
- Systemic arterial blood pressure
- The long-term effect of accelerated pacing on:
- HRQoL, based on the MLHFQ and SF-36 questionnaires.
- NT-proBNP levels
- Device detected AF burden
- Device detected daily activity comparing accelerated- vs control rate
- Echocardiographic measurements (LVEF, LVEDD, LVESD, LAVI, LA strain)
- Symptoms experienced as a result of (accelerated) pacing based on the AFEQT questionnaire
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation, Persistent Atrial Fibrillation, Pacemaker DDD, Paroxysmal Atrial Fibrillation
- Being tested
- Accelerated pacing, Current standard of care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated pacingDevice
The lower rate of the pacemaker will be programmed to 80 bpm in DDDR mode with mode switch to DDIR mode.
Current standard of careDevice
The lower rate of the pacemaker will be programmed to the current standard of care which is 60 bpm in DDDR mode with mode switch to DDIR mode.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated pacing (lower rate pacemaker 80bpm) | Experimental | Patients in the experimental arm will have their pacemaker programmed to a lower rate of 80bpm. Receives: Device: Accelerated pacing |
| Current standard of care (lower rate pacemaker 60bpm) | Active comparator | Patients in the control arm will have their pacemaker programmed to a lower rate of 60bpm, which is the current standard of care. Receives: Device: Current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
The primary endpoint of this study is the difference in HRQoL, measured with the Minnesota Living with Heart Failure Questionnaire (MLHFQ), between patients programmed to accelerated pacing with a lower rate of 80 bpm (intervention) compared to current standard of care with a lower rate of 60 bpm (control). The score in the MLHFQ can range between 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Measured: 6 months after the AV node ablation
Secondary outcomes (13)
The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP).
The acute effect of various accelerated pacing rates on PCWP measured by a right heart catheterization during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP.
Measured: At the AV node ablation
The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO).
The acute effect of various accelerated pacing rates on CO measured by a right heart catheterization during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP.
Measured: At the AV node ablation
The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure.
The acute effect of various accelerated pacing rates on arterial blood pressure measured invasively in the femoral artery during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP.
Measured: At the AV node ablation
The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on HRQoL measured by the SF-36 questionnaire.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on NTproBNP levels.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on device detected AF burden.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on device detected daily activity.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on LVEF.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on LVEDD.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on LVESD.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on LAVI.
Measured: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
The long-term (6 months) effects of accelerated pacing on LA-strain.
Measured: 6 months after the AV node ablation
Palpitations experienced as a result of (accelerated) pacing.
Palpitations experienced as a result of (accelerated) pacing based on the AF effect on quality of life (AFEQT) questionnaire. Patients can score between 0 and 100, with a lower score meaning a worse outcome.
Measured: 6 months after the AV node ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single center, prospective, single blinded, parallel group, pilot-trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377046
- Sponsor's protocol ID
- NL86643.068.24
- Acronym
- PACE-AF
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated PACing for Improved Quality of lifE in Symptomatic Atrial Fibrillation Patients Undergoing Pace-and-ablate Strategy With Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF
- ClinicalTrials.gov ID
- NCT06377046
- Acronym / sponsor ID
- PACE-AF / NL86643.068.24
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation, Persistent Atrial Fibrillation, Pacemaker DDD, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 Apr 2024 (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 goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.
The main question it aims to answer is:
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.
Secondary questions it aims to answer are:
- To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.
- To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:
- NT pro BNP levels
- device detected atrial fibrillation burden and daily activity
- echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain
Detailed description
Rationale:
Permanent pacemaker implantation combined with atrioventricular node ablation (AVNA) reduces symptoms and improves health-related quality of life (HRQoL) in patients with symptomatic atrial fibrillation (AF). A high percentage of conventional right ventricular pacing increases the risk for pacing-induced cardiomyopathy, a risk which is presumably minimised by a form of conduction system pacing, termed left bundle branch area pacing (LBBAP). LBBAP attempts to recreate the normal physiologic activation of the heart through stimulation of the heart's own natural conduction system, thereby maintaining ventricular synchrony. This strategy may be particularly important in patients with heart failure with preserved ejection fraction (HFpEF), a diagnosis that frequently coexists with AF. The long-term programming of a patient undergoing a "pace-and-ablate strategy" (pacemaker implantation and AVNA), is such that the lower rate of the pacemaker is routinely set to 60 bpm. Previous studies have shown that accelerated pacing (ie. programming the pacemaker to a lower rate of 80bpm) may improve HRQoL in a subset of patients with HFpEF. It is therefore hypothesized that accelerated pacing will improve HRQoL in patients with symptomatic AF undergoing a pace and ablate strategy, when compared to pacing at 60 bpm, which is standard of care.
Objective:
Primary objective: To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
Secondary objectives:
- To study, in a subset of participants who give informed consent, the acute hemodynamic effect of accelerated pacing rates on pulmonary capillary wedge pressure (PCWP), cardiac output and arterial blood pressure, among AF patients undergoing a pace-and-ablate strategy with LBBAP.
- To study the long-term (6 months) effects of accelerated pacing among AF patients undergoing a pace-and-ablate strategy with LBBAP by measuring NT-proBNP levels, device detected AF-burden and daily activity, by evaluating HRQoL questionnaires (SF-36), and by assessing echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end-diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain) compared to pacing at the standard of care lower rate of 60bpm.
- To investigate whether participants experience symptoms of accelerated pacing (such as palpitations), based on the Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire, compared to standard of care.
Study design:
Randomized, single center, prospective, single blinded, parallel group, pilot-trial.
Study population:
Patients ≥ 18 years with symptomatic AF undergoing pace-and-ablate strategy.
Intervention:
- 1:1 randomization to a lower rate of DDDR 80 bpm (intervention) or a lower rate of DDDR 60 bpm (control). Duration of the study is 6 months.
In a subset of participants:
- Right heart catheterisation and invasive blood pressure measurements will be conducted to evaluate acute hemodynamic effects of different (accelerated) ventricular pacing rates during the standard of care AV node ablation.
Main study parameters/endpoints:
Primary endpoint:
Difference in HRQoL between a lower rate of 80 bpm and a lower rate of 60 bpm, based on the Minnesota Living with Heart Failure Questionnaire (MLHFQ), determined at 6 months follow-up.
Secondary endpoints:
- The acute hemodynamic effects of (accelerated) pacing at time of AVNA:
- Pulmonary Capillary Wedge Pressure (PCWP)
- Cardiac Output (CO)
- Systemic arterial blood pressure
- The long-term effect of accelerated pacing on:
- HRQoL, based on the MLHFQ and SF-36 questionnaires.
- NT-proBNP levels
- Device detected AF burden
- Device detected daily activity comparing accelerated- vs control rate
- Echocardiographic measurements (LVEF, LVEDD, LVESD, LAVI, LA strain)
- Symptoms experienced as a result of (accelerated) pacing based on the AFEQT questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single center, prospective, single blinded, parallel group, pilot-trial.
| Arm | Type | Receives |
|---|---|---|
| Accelerated pacing (lower rate pacemaker 80bpm) | Experimental | Device: Accelerated pacingPatients in the experimental arm will have their pacemaker programmed to a lower rate of 80bpm. |
| Current standard of care (lower rate pacemaker 60bpm) | Active comparator | Device: Current standard of carePatients in the control arm will have their pacemaker programmed to a lower rate of 60bpm, which is the current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults > 18 years of age
- Referred for pace-and-ablate strategy with LBBAP for symptomatic AF
- Left ventricular ejection fraction ≥ 40%.
- Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent.
Key exclusion criteria (4 listed)
- Infiltrative or constrictive cardiomyopathy (cardiac amyloidosis/sarcoidosis/ constrictive pericarditis)
- Severe Valvular heart disease (more than moderate valvular stenosis or regurgitation, aortic or mitral valve replacement)
- Patient participating in another interventional clinical trial
- Recent (< 3 months) Myocardial infarction (MI), Transient Ischemic Attack or Cerebro- Vascular Accident
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 |
|---|---|---|
| Accelerated pacingThe lower rate of the pacemaker will be programmed to 80 bpm in DDDR mode with mode switch to DDIR mode. | Device | Accelerated pacing (lower rate pacemaker 80bpm) |
| Current standard of careThe lower rate of the pacemaker will be programmed to the current standard of care which is 60 bpm in DDDR mode with mode switch to DDIR mode. | Device | Current standard of care (lower rate pacemaker 60bpm) |
Primary outcome
The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
Time frame: 6 months after the AV node ablation
The primary endpoint of this study is the difference in HRQoL, measured with the Minnesota Living with Heart Failure Questionnaire (MLHFQ), between patients programmed to accelerated pacing with a lower rate of 80 bpm (intervention) compared to current standard of care with a lower rate of 60 bpm (control). The score in the MLHFQ can range between 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
13 secondary outcomes
The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP).
Time frame: At the AV node ablation
The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO).
Time frame: At the AV node ablation
The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure.
Time frame: At the AV node ablation
The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.
Time frame: 6 months after the AV node ablation
Palpitations experienced as a result of (accelerated) pacing.
Time frame: 6 months after the AV node ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated pacing in people with Atrial Fibrillation and Permanent Atrial Fibrillation, run by Maastricht University Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Vernooy, MD, PhD (+31433877095, kevin.vernooy@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP. (time frame: 6 months after the AV node ablation). 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 22 Apr 2024.