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Completed

NCT Number: NCT06592690

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

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

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Key information

Conditions

Heart Failure, Wide QRS Complex Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Centrale di Bolzano

Bolzano, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrial pacing support

Other

Use a pacing mode with atrial pacing including a rate-resposive sensor.

Atrial tracking pacing mode

Other

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.

Primary outcomes

  1. distance walked during the 6MWT

    Time frame: A consecutive 6-month treatment period with the same pacing mode.

    distance walked during the 6-minute-walking-test (6MWT)

Sponsors and collaborators

Lead sponsor

Ospedale Centrale Bolzano

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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