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

NCT06592690 | Completed

• 1 other identifier: 0100843-BZ
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure, Wide QRS Complex

Keywords

atrial pacing; cardiac resynchronization therapy; heart failure; implantable cardioverter defibrillator; rate-adaptive pacing

Outcome Measures

Primary Outcomes (1)

• distance walked during the 6MWT

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

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

Study Arms (2)

VDD

ACTIVE COMPARATOR

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.

Other: Atrial tracking pacing mode

DDDR

EXPERIMENTAL

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.

Other: Atrial pacing support

Interventions

Atrial pacing support OTHER

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

DDDR

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.

VDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Centrale Bolzano: lead

Study Sites (1)

Ospedale Centrale di Bolzano

Bolzano, Italy

Location

Related Publications (1)

• Donazzan L, Bulian F, Maines M, Erckert M, Peruzza F, Rauhe WG, Giacopelli D, Manfrin M. Effect of rate-adaptive atrial support compared to VDD pacing in cardiac resynchronization therapy recipients: A randomized cross-over study. Am Heart J. 2025 Mar;281:149-156. doi: 10.1016/j.ahj.2024.12.005. Epub 2024 Dec 17.

  PMID: 39701488 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: Randomized, cross-over, double-blind, multicenter study

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 27, 2017
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)