Trajectory Changes of Coronary Sinus Lead Tip and Cardiac Resynchronization Therapy Outcome

NCT02340546 | Completed

• 1 other identifier: 1368/2014
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 7

Brief Summary

In chronic systolic heart failure patients submitted to cardiac resynchronization therapy, the study aims at assessing whether geometric variations in coronary sinus lead tip trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are predictive of the volumetric and clinical response to the treatment at six-month follow-up.

Conditions

Heart Failure; Left-Sided Heart Failure; Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• the two-dimensional echocardiographic volumetric response to cardiac resynchronization therapy

  the volumetric response to cardiac resynchronization therapy defined by a reduction equal or greater than 15% in two-dimensional echocardiographic end-systolic volume (ml) at six-month in comparison with pre-implant assessment;

  six months

Secondary Outcomes (1)

• the clinical response to cardiac resynchronization therapy depicted by three metrics

  six months

Interventions

cardiac resynchronization therapy DEVICE

cardiac resynchronization by means of biventricular pacing via left ventricular pace from coronary sinus veins combined with conventional any-site right ventricular pace

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

patients with chronic systolic heart failure who are submitted to a cardiac resynchronization therapy device implant, with either pacemaker or implantable cardioverter-defibrillator capabilities, as a first implant or as an upgrade from a previously implanted cardiac electric device, who exhibit a normofrequent regular ventricular rhythm.

You may qualify if:

• Informed consent;
• chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction ≤ 35%) and NYHA II-III or ambulatory IV class symptoms despite optimal medical treatment;
• QRS complex on the surface electrocardiogram with left bundle branch block morphology and duration ≥ 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; QRS with with non-specific intraventricular delay lasting ≥ 150 ms;
• a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly ≤ 45 beats per minute;
• no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously;
• a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate ≤ 25 breaths per minute;

You may not qualify if:

• inability to give informed consent;
• occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months;
• any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats;
• participation in any other competing clinical study, with the exception of registries ruled by National Health Service Authorities or Agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects:
• the program of procedures/assessments requested by the present study;
• the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients.

Sponsors & Collaborators

• Corrado Tomasi: lead
• University of Bologna: collaborator

Study Sites (7)

Poiliclinico Sant'Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Ospedale Maurizio Bufalini

Cesena, FC, 47521, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, RA, 48121, Italy

Location

Ospedale Mater Salutis

Legnago, Verona, 37045, Italy

Location

Ospedale Classificato Equiparato Sacro Cuore - Don Calabria -

Negrar, VR, 37024, Italy

Location

Ospedale S Maria della Misericordia - AUSL 18 del Veneto

Rovigo, 45100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Corrado Tomasi, M D

  Ospedale Santa Maria delle Croci, Ravenna, Italy

  PRINCIPAL INVESTIGATOR

• Stefano Severi, Engeneer

  University of Bologna

  STUDY DIRECTOR

• Cristiana Corsi, Engeneer

  Engeneering Department , University of Bologna, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist, Chief Electrophisiologist of the Cardiovascular Department

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

IT (7)