Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy

February 15, 2023 updated by: Anja Zupan Mežnar, University Medical Centre Ljubljana
This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV) resynchronization with His bundle pacing in patients with symptomatic first degree AV block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The term AV dyssynchrony was introduced by Salden F. and coauthors in 2018. It stands for the adverse effects of AV dyssynchrony due to PR interval prolongation. According to the ESC and ACC guidelines, severe first degree AV block is an IIa indication for permanent pacemaker implantation, yet data on these patients' clinical outcomes are scarce. To independently determine the impact of AV resynchronization, His bundle pacing will be used to avoid intraventricular desynchronization.

Symptomatic patients with severe first-degree AV block and echocardiographically proven AV dyssynchrony will be included in the study.

All patients will receive a dual-chamber pacemaker with an atrial lead positioned in the right atrium and ventricular lead placed on the bundle of His. In a single-blind cross-over design, patients will be randomized to AV sequential His bundle pacing with echo-guided AV optimization or back-up VVI pacing mode. Each study period will last for three months. At the end of both periods, cardiopulmonary exercise testing, complete echocardiographic study, and clinical evaluation will be performed.

Peak oxygen uptake and echocardiography-based hemodynamic parameters in both periods will be compared.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First OR second degree Mobitz type 1 atrioventricular block with a PR interval > 250 ms
  • left ventricular ejection fraction > 50%
  • echocardiographic criteria of atrioventricular dyssynchrony (diastolic filling time/RR interval ratio < 0,4 OR fusion of E and A waves OR diastolic mitral regurgitation)
  • symptoms on exertion (dyspnea, palpitations)
  • insufficient shortening of PR interval during exercise (PR interval > 200 ms at heart rate of 100 beats per minute)

Exclusion Criteria:

  • left ventricular ejection fraction < 50%
  • third degree atrioventricular block
  • atrial fibrillation
  • sinus node disease
  • left bundle branch block
  • right bundle branch block
  • ventricular arrhythmia that indicates implantation of cardioverter defibrillator
  • consumption of drugs that influence atrioventricular conduction
  • active bacterial infection
  • inability to undergo cardiopulmonary exercise test
  • anaemia (haemoglobin concentration < 100 g/L)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: His bundle pacing, AV optimized
Pacemaker programmed to DDD mode with ventricular lead placed on the bundle of His and echocardiographically optimized AV delay.
Device: His bundle pacing, AV optimized
A Select Secure 3830 (Medtronic, MN, USA) pacing lead will be placed on the bundle of His. In case of unsuccessful His capture, left bundle branch area pacing is going to be targeted. Pacemaker will be programmed to a low base rate and a high tracking rate to allow for intrinsic sinus rhythm. AV delay will be optimized with echocardiography to the shortest AV delay without truncation of the A wave on transmitral pulse wave doppler.
Sham Comparator: Backup VVI pacing
Pacemaker programmed to ventricular only pacing with low base rate (40/min) to allow intrinsic rhythm.
Device: Backup VVI pacing
Pacemaker will be programmed to VVI (ventricular only) mode with low base rate as to allow for intrinsic sinus rhythm without AV optimization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in exercise capacity
Time Frame: Baseline, 3 months, 6 months
Measured by peak oxygen consumption on cardiopulmonary exercise test
Baseline, 3 months, 6 months
Changes in left ventricular stroke volume
Time Frame: Baseline, 3 months, 6 months
Measured by echocardiography
Baseline, 3 months, 6 months
Changes in quality of life using the 5 level EQ-5D questionnaire
Time Frame: Baseline, 3 months, 6 months
EQ-5D is a standardized measure of health status consisting of 2 pages - the EQ-5D descriptive system (descriptive system with five levels) and the EQ visual analog scale ranging from 0 (worst state) to 100 (best state).
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in left ventricular volume
Time Frame: Baseline, 3 months, 6 months
End diastolic volume measured echocardiographicaly with biplane Simpson method
Baseline, 3 months, 6 months
Changes in left atrial volume
Time Frame: Baseline, 3 months, 6 months
Left atrial volume indexed by body surface area measured by echocardiography
Baseline, 3 months, 6 months
Changes in the measure of left ventricular mechanical dyssynchrony
Time Frame: Baseline, 3 months, 6 months
Measured by mid-ventricular radial speckle-tracking strain with an anteroseptal to posterior wall delay (AS-P delay)
Baseline, 3 months, 6 months
Changes in QRS complex width
Time Frame: Baseline, 3 months, 6 months
Measured by electrocardiogram
Baseline, 3 months, 6 months
Changes in pacing thresholds
Time Frame: Baseline, 3 months, 6 months
Measured during device check
Baseline, 3 months, 6 months
Changes in sensing of R wave
Time Frame: Baseline, 3 months, 6 months
Measured during device check
Baseline, 3 months, 6 months
Changes in lead impedance
Time Frame: Baseline, 3 months, 6 months
Measured during device check
Baseline, 3 months, 6 months
Fluoroscopy time
Time Frame: Baseline
Time of fluoroscopy use during device implantation
Baseline
Adverse events
Time Frame: through study completion, an average of one year
Any of the following adverse events: pocket hematoma, pneumothorax, hemothorax, cardiac tamponade, lead dislocation, lead perforation, cardiac implantable device infection
through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCLj-AVdromHis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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