Conduction System Pacing Optimized Therapy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-27

Study Completion Date

2023-11-02

Brief Summary

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The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months.

Group Type EXPERIMENTAL

Left ventricular coronary sinus (BiV) configuration

Intervention Type DEVICE

For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.

Conduction system pacing-only configuration

Intervention Type DEVICE

Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.

Conduction System Pacing Optimized Therapy (CSPOT) configuration

Intervention Type DEVICE

A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.

Interventions

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Left ventricular coronary sinus (BiV) configuration

For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.

Intervention Type DEVICE

Conduction system pacing-only configuration

Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.

Intervention Type DEVICE

Conduction System Pacing Optimized Therapy (CSPOT) configuration

A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is willing and able to provide written informed consent
* Subject is at least 18 years of age
* Patient is willing and able to comply with the protocol, including follow-up visits
* The patient's medical records must be accessible by the enrolling site over the follow-up period
* Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
* De-novo CRT implant, including upgrade from pacemaker or ICD

Exclusion Criteria

* Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
* Subject has 2nd or 3rd degree AV (Atrioventricular) Block
* Subject has RBBB with no additional conduction block
* Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
* Subject experienced MI within 40 days prior to enrollment
* Subject underwent valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation or is actively listed on the transplantation list
* Subject is implanted with a LV assist device
* Subject has severe renal disease
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm or significant valve disease expected to be operated within study period)
* Subject has severe aortic calcification or severe peripheral arterial disease
* Subject has complex and uncorrected congenital heart disease
* Subject has mechanical heart valve
* Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
* Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No