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NOT YET RECRUITING
NCT06377046
NA

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-05

Completion Date

2026-05

Last Updated

2024-04-22

Healthy Volunteers

No

Interventions

DEVICE

Accelerated pacing

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

DEVICE

Current standard of care

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.