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

Not Applicable

Completed

• Conditions: Heart Failure, Wide QRS Complex
• Interventions: Other: Atrial tracking pacing mode; Other: Atrial pacing support

• Registration Number: NCT06592690
• Lead Sponsor: Ospedale Centrale Bolzano

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-11-27
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-17
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VDD	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.
DDDR	Atrial pacing support	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.

Primary Outcome Measures

Name	Time	Method
distance walked during the 6MWT	A consecutive 6-month treatment period with the same pacing mode.	distance walked during the 6-minute-walking-test (6MWT)

Trial Locations

Locations (1)

Ospedale Centrale di Bolzano; 🇮🇹 Bolzano, Italy