Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy

NCT ID: NCT02748876

Last Updated: 2019-07-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-29

Study Completion Date

2018-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).

The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.

The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

His-Ventricular (HV)-optimised

His-Ventricular (HV) optimised atrioventricular delay

Group Type EXPERIMENTAL

His-Ventricular (HV) optimisation

Intervention Type OTHER

Optimisation of atrioventricular pacing interval

Non-optimised

Standard atrioventricular delay

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

His-Ventricular (HV) optimisation

Optimisation of atrioventricular pacing interval

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of heart failure
* Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
* In sinus rhythm
* Patients must have a telephone
* Ability to give informed consent
* Ability to complete the study

Exclusion Criteria

* Severe valve disease or previous valve replacement
* Previous atrial flutter ablation
* Chronic kidney disease Stage 3 or above
* Recent myocardial infarction
* Ongoing cardiac ischaemia
* Infiltrative cardiomyopathy
* Wolff-Parkinson White syndrome
* Presence of second or third degree heart block
* \<90% biventricular pacing at 3 months
* Hypertrophic cardiomyopathy
* Pregnancy or breastfeeding
* On treatment for hypothyroidism or hyperthyroidism
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Castle Hill Hospital

Hull, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Optimizing CRT With ECGI
NCT03492788 TERMINATED NA
Cardiac Resynchronisation Study
NCT01213537 COMPLETED
Pacing in Heart Failure With Preserved LVEF
NCT03215849 ENROLLING_BY_INVITATION NA