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Accelerated Pacing for Improved Quality of Life in Symptomatic Atrial Fibrillation Patients undergoing Pace-and-Abate Strategy with Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF

Accelerated Pacing for Improved Quality of Life in Symptomatic Atrial Fibrillation Patients undergoing Pace-and-Abate Strategy with Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF - PACE-AF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57043
Enrollment
50
Registered
2024-04-11
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrialfibrillation Supraventricular tachycardia

Interventions

- 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 catheterisa

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults >18 years of age Referred for AVNA as part of an pace-and-ablate strategy with LBBAP for symptomatic AF symptomatic AF Left ventricular ejection fraction >40% Willingness to participate, to understand the intructions and fill out the  questionnaires

Exclusion criteria

Exclusion criteria: Infiltrative or constrictive cardiomyopathy Severe valvular heart disease Participation in another interventional clinical trial recent myocardial infacrtion, Transient Ischemic Attack, Cerebro-vascular accident

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- The acute hemodynamic effects of (accelerated) pacing at time of AVNA: o Pulmonary Capillary Wedge Pressure (PCWP) o Cardiac Output (CO) o Systemic arterial blood pressure - The long-term effect of accelerated pacing on: o HRQoL, based on the MLHFQ and SF-36 questionnaires. o NT-proBNP levels o Device detected AF burden o Device detected daily activity comparing accelerated- vs control rate o Echocardiographic measurements (LVEF, LVEDD, LVESD, LAVI, LA strain) - Symptoms experienced as a result of (accelerated) pacing based on the AFEQT questionnaire

Countries

Canada, Netherlands

Contacts

Public ContactJ Koll

Maastricht Universitair Medisch Centrum +

secretariaat.HVC@mumc.nl043 387 27 27

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026