Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients

Ospedale Centrale Bolzano

Status: Completed

Conditions: Heart Failure, Wide QRS Complex

Treatments: Other: Atrial pacing support; Other: Atrial tracking pacing mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06592690

0100843-BZ

Details and patient eligibility

About

This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.

Full description

Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.

Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.

The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
• Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
• Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.

Exclusion criteria

• Permanent Atrial Fibrillation;
• Inability to perform 6MWT;
• Suboptimal HF drug therapy;
• Heart rate at rest above 50 bpm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups

VDD

Active Comparator group

Description:

A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria.

Treatment:

Other: Atrial tracking pacing mode

DDDR

Experimental group

Description:

DDDR pacing mode added atrial support to these using an accelerometer-based rate-responsive sensor which should be able to increase heart rate when needed.

Treatment:

Other: Atrial pacing support