Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure

NCT04420065 | Unknown DMC FDA Device

• 1 other identifier: READAPT
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized trial of adult patients to study the effects of preferential left ventricular pacing on ventriculoarterial coupling of both systemic and pulmonary circulation, indices of systolic and diastolic function of both ventricles, and clinical course of patients with advances dyssynchronous heart failure.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart failure; Cardiac resynchronization therapy; Preferential left ventricular pacing; Ventriculoarterial coupling; Echocardiography; Cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• Changes in patient exercise capacity

  Assessed by cardiopulmonary exercise test in terms of maximal oxygen consumption in ml/kg/min

  12 months

Secondary Outcomes (4)

• Number of hospitalizations for heart failure

  12 months

• Left ventricular function

  12 months

• Right ventricular function

  12 months

• Ventriculoarterial coupling for both systemic and pulmonary circulation

  12 months

Study Arms (2)

Classical biventricular pacing

ACTIVE COMPARATOR

Commercially available LV-pacing capable CRT devices and quadripolar leads will be implanted. Right ventricular (RV) and right atrial (RA) leads will be placed according to standard practice. The LV lead will also be placed according to standard practice, targeting to a lateral, posterolateral, or anterolateral branch of the coronary sinus (CS). Interventricular delay programmed will be determined based on stroke volume maximization, and will be used as a criterion for BVP optimization. Atrioventricular delay optimization shall be automatically performed by the device.

Device: Biventricular pacing

Preferential left ventricular pacing

EXPERIMENTAL

In G2 patients, an algorithm for preferential left ventricular pacing will be activated. Following selection of the dipole maximizing stroke volume during simultaneous LV-RV pacing, subsequent V-V delay optimization shall be delegated to the algorithm. Based on previous studies, a subgroup analysis of G2 will be performed, comparing those receiving ≥50% with those receiving \<50% preferential LV pacing evaluated over the total duration of the study (12 months).

Device: Preferential left ventricular pacing

Interventions

Preferential left ventricular pacing DEVICE

Activation of an algorithm attempting to provide preferential left ventricular pacing in an anticipatory manner, thus potentially preventing iatrogenic, pacing-related, right ventricular dysfunction, and improving coupling and outcomes in dyssynchronous heart failure patients

Preferential left ventricular pacing

Biventricular pacing DEVICE

Standard biventricular pacing, with V-V delay programmed based on stroke volume maximization, and A-V delay delegated to the device

Classical biventricular pacing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old Provided informed consent Any cardiomyopathy type, diagnosed at least 6 months prior (to exclude recent myocarditis cases that may remit and confound outcomes) On optimal medical therapy for at least 3 months, An existing I/IIa indication for a CRT-D device Both new CRT-D implantation and an upgrade from an existing ICD or pacemaker with no prior left ventricular lead placement.

You may not qualify if:

• Have an existing Class I recalled lead,
• Are anticipated to need heart transplantation within the next 9 months,
• Have undergone cardiac transplantation less than 40 days prior to enrolment,
• Have had a cerebrovascular accident or transient ischemic attack within 3 months of enrollment,
• Have had a recent myocardial infarction less than 40 days prior to enrollment, or unstable angina or cardiac revascularization less than 3 months prior to enrolment,
• Have documented moderate to severe/severe mitral/aortic/tricuspid/pulmonary insufficiency (noninvasive VAC calculation impossible),
• Exhibit a daily burden of premature ventricular complexes (PVCs) of either ≥10% of total QRSs or ≥10,000 on ambulatory ECG recording21, 22 (to exclude PVC-related, potentially reversible cardiomyopathy),
• Are currently participating in a clinical investigation that includes an active treatment arm,
• Have diagnosed pulmonary hypertension other than class II (left heart-related),
• Have known stage IV-V renal dysfunction (clearance estimated by the Cockcroft-Gault equation),
• Have permanent atrial fibrillation,
• Have complete atrioventricular block,
• Have a prolonged (\>200msec) PQ interval on surface ECG (thus invalidating the option for preferential LV pacing),
• Are pregnant or planning to become pregnant during the duration of the study (in case of unplanned pregnancy the patient will have to be excluded from the study),
• Have an expected life expectancy of \<12 months, or

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

First University Department of Cardiology, Hippokrateion General Hospital

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Christina Chrysohoou, MD PhD

CONTACT

00306944435168; chrysohoou@usa.net

Christos-Konstantinos Antoniou, MD PhD

CONTACT

00306972708430; ckantoniou@hotmail.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient and assessor unaware of chosen programming mode and activated algorithms. The standard of care that is biventricular pacing will be provided to all participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Consultant, Director of Cardiology, Senior Researcher

Model Details: Patients randomized after enrollment to receive either standard biventricular pacing, or preferential left ventricular pacing (left ventricle will be resynchronized, but right ventricle will be activated through the intrinsic conduction system)

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data to be shared 2 years after study completion
• Access Criteria: Request made by investigator with an active, registered clinical trial

Locations

GR (1)