Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial

NCT06377046 | Not Yet Recruiting

• 1 other identifier: NL86643.068.24
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Atrial Fibrillation; Permanent Atrial Fibrillation; Persistent Atrial Fibrillation; Pacemaker DDD; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  At the AV node ablation

• The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO).

  At the AV node ablation

• The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure.

  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.

  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.

  6 months after the AV node ablation

Study Arms (2)

Accelerated pacing (lower rate pacemaker 80bpm)

EXPERIMENTAL

Patients in the experimental arm will have their pacemaker programmed to a lower rate of 80bpm.

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.

Device: Current standard of care

Interventions

Accelerated pacing DEVICE

The lower rate of the pacemaker will be programmed to 80 bpm in DDDR mode with mode switch to DDIR mode.

Accelerated pacing (lower rate pacemaker 80bpm)

Current standard of care DEVICE

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.

Current standard of care (lower rate pacemaker 60bpm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kevin Vernooy, MD, PhD

CONTACT

+31433877095; kevin.vernooy@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single center, prospective, single blinded, parallel group, pilot-trial.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04