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Completed

NCT Number: NCT01573091

Cardiac Resynchronization Therapy Modular Registry

The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Degli Infermi, Biella, Italy

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About this study

Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic symptomatic HF despite stable, optimal drug therapy
  • Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines
  • Patients implanted with cardiac resynchronization device

Exclusion criteria

  • Patients participating in other studies that clearly impact the clinical practice of the center
  • Patients who are unable to provide informed consent
  • Patients who can not perform follow-up in the center

Treatment and study plan

Cardiac resynchronization therapy

Procedure

Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines

Primary outcomes

  1. Clinical response

    Time frame: 24 months

    Improvement in functional class status by at least one NYHA Class or remain in functional class II

  2. Echocardiographic response of absolute increase of ≥5% in LVEF

    Time frame: 24 months

    Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%

  3. Echocardiographic response of ≥15% reduction in LVESV

    Time frame: 24 months

    Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%

Secondary outcomes

  1. LV lead/RV lead geometric distance

    Time frame: 12 months

    To investigate the correlation of LV lead/RV lead geometric distance (as measured by fluoroscopy) and reverse remodeling in cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The relation with LVESVi change between baseline and 12 months will be analyzed.

  2. Change from baseline in R wave in 12-lead ECG at 12 months

    Time frame: 12 months

    To investigate the relationship between the ECG characteristics at baseline and response to cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The purpose of this objective is to evaluate the R wave in 12-lead ECG during BIV, RV and LV pacing and change from baseline at 12 months.

  3. Number of ventricular arrhythmias after cardiac resynchronization therapy

    Time frame: 24 months

    To investigate the relationship between LV pacing and the number of ventricular tachycardia/fibrillation and/or appropriate/inappropriate shocks. The number and type of arrhythmia before and after upgrading to CRT device at 24 months will be analyzed

Sponsors and collaborators

Lead sponsor

Giuseppe Ricciardi

Other

Registry information

Acronym: CRT-MORE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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