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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2021-09-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure, Wide QRS Complex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, cross-over, double-blind, multicenter study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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VDD

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.

Group Type ACTIVE_COMPARATOR

Atrial tracking pacing mode

Intervention Type 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.

DDDR

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.

Group Type EXPERIMENTAL

Atrial pacing support

Intervention Type OTHER

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

Interventions

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Atrial pacing support

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

Intervention Type OTHER

Atrial tracking pacing mode

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.

Intervention Type OTHER

Eligibility Criteria

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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.