Cardiac Resynchronization Therapy Modular Registry

NCT01573091 | Completed

• 1 other identifier: 2011/0043537
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Heart Failure

Keywords

Cardiac resynchronization therapy; Heart failure

Outcome Measures

Primary Outcomes (3)

• Clinical response

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

  24 months

• Echocardiographic response of absolute increase of ≥5% in LVEF

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

  24 months

• Echocardiographic response of ≥15% reduction in LVESV

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

  24 months

Secondary Outcomes (3)

• LV lead/RV lead geometric distance

  12 months

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

  12 months

• Number of ventricular arrhythmias after cardiac resynchronization therapy

  24 months

Study Arms (1)

Heart failure patients

Patients with a CRT device according to current guidelines

Procedure: Cardiac Resynchronization Therapy

Interventions

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

Heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for CRT device implanted according to current guidelines

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giuseppe Ricciardi: lead

Study Sites (12)

Ospedale Degli Infermi

Biella, Biella, 61679, Italy

Location

San Giacomo e Cristoforo

Massa, Massa, 54100, Italy

Location

Azienda Ospedaliera di Padova

Padua, Padova, 61353, Italy

Location

Azienda Ospedaliera San Salvatore

Pesaro, Pesaro, 61998, Italy

Location

Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza

Brescia, 25124, Italy

Location

Department of Heart and Vessels, University of Florence

Florence, 50134, Italy

Location

Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate

Gallarate, 21013, Italy

Location

Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma

Mantova, 46100, Italy

Location

Department of Heart, Electrophysiology, Clinica Mediterranea

Naples, 80122, Italy

Location

Azienda Ospedale dei Colli - Monaldi

Napoli, 80131, Italy

Location

Policlinico Federico II

Napoli, Italy

Location

Department of Cardiology, Ospedale Civile "Misericordia e Dolce"

Prato, 59100, Italy

Location

Related Publications (3)

• Bertaglia E, Reggiani A, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Arena G, Marini M, Ricciardi G, Badolati S, Spotti A, Solimene F, Ferraro A, Migliore F, Botto GL, Malacrida M, Stabile G. The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria. Int J Cardiol. 2018 Dec 15;273:162-167. doi: 10.1016/j.ijcard.2018.09.027. Epub 2018 Sep 8.

  PMID: 30217421 DERIVED

• Stabile G, Pepi P, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Rapacciuolo A, Arena G, Marini M, Pieragnoli P, Badolati S, Savarese G, Maglia G, Iuliano A, Botto GL, Malacrida M, Bertaglia E. Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy. Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.

  PMID: 29665405 DERIVED

• Stabile G, D'Onofrio A, Pepi P, De Simone A, Santamaria M, Caico SI, Rapacciuolo A, Padeletti L, Pecora D, Giovannini T, Arena G, Spotti A, Iuliano A, Bertaglia E, Malacrida M, Botto GL. Interlead anatomic and electrical distance predict outcome in CRT patients. Heart Rhythm. 2015 Nov;12(11):2221-9. doi: 10.1016/j.hrthm.2015.05.020. Epub 2015 May 19.

  PMID: 26001509 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Luigi Padeletti, MD

  Department of Heart and Vessels, University of Florence, Florence, Italy.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 6, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)