Central Haemodynamics and Pacing for AV Block

NCT ID: NCT07276490

Last Updated: 2025-12-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2027-12-31

Brief Summary

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A randomized, single-blind study comparing two pacing strategies in patients with atrioventricular block requiring permanent pacemaker implantation. This trial evaluates the impact of conduction system pacing (left bundle branch area pacing) versus standard right ventricular pacing on central hemodynamics, cardiac function, and patient quality of life over 12 months. The study will enroll 124 patients from two Estonian tertiary hospitals and measure central systolic arterial pressure as the primary outcome, with secondary assessments of arterial stiffness, echocardiographic parameters, electrical activation patterns, and quality of life scores.

Detailed Description

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Conditions

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Atrioventricular Block Pacing Therapy Right Ventricular Pacing Conduction System Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Right ventricular pacing

Group Type ACTIVE_COMPARATOR

Right ventricular pacing

Intervention Type DEVICE

Pacemaker implantation with RV lead placement

Conduction system pacing

Group Type EXPERIMENTAL

Conduction system pacing

Intervention Type DEVICE

Pacemaker implantation with conduction system (LBBAP) lead placement

Interventions

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Right ventricular pacing

Pacemaker implantation with RV lead placement

Intervention Type DEVICE

Conduction system pacing

Pacemaker implantation with conduction system (LBBAP) lead placement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years
* Diagnosis of atrioventricular block
* Expected survival \>1 year

Exclusion Criteria

* Reduced left ventricular ejection fraction (EF \<45%)
* Expected ventricular pacing burden \<20%
* Inter-arm systolic blood pressure difference \>15 mmHg
* Percutaneous coronary intervention or coronary artery bypass surgery within the last 30 days
* Secondary hypertension
* Orthostatic hypotension
* Clinically significant valvular heart disease
* Congenital heart disease
* Pulse wave analysis or pulse wave velocity measurement cannot be reliably performed
* Pregnancy or breastfeeding
* Withdrawal of consent by the subject
* Loss of contact during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Estonia Medical Centre

OTHER

Sponsor Role collaborator

Tartu University Hospital

OTHER

Sponsor Role collaborator

University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Silver Heinsar

Clinical researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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North Estonia Medical Centre

Tallinn, Harju, Estonia

Site Status RECRUITING

Countries

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Estonia

Central Contacts

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Silver Heinsar, MD, PhD

Role: CONTACT

+372 5333 1997

Facility Contacts

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Silver Heinsar, MD, PhD

Role: primary

+372 5333 1997

Other Identifiers

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405/M-27

Identifier Type: -

Identifier Source: org_study_id

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