CCM Italian Registry

Summary

The Cardiac Contractility Modulation (CCM) system is a cardiac implantable device indicated for the treatment of patients with symptomatic heart failure with left ventricular systolic dysfunction despite optimal medical and electrical therapy. This system consists of a generator to which two stimulation leads are connected, which are fixed on the interventricular septum and deliver non-excitatory electrical signals during the absolute ventricular refractory period, with the aim of influencing the contractility properties of the myocardium in patients with chronic heart failure. Clinical data indicate that CCM therapy is safe and effective for the treatment of patients with symptomatic heart failure with reduced left ventricular systolic function, in which a significant improvement in quality of life and exercise tolerance has been shown, together with an impact on hospitalizations for heart failure.

This prospective registry includes patients undergoing CCM implantation for the above clinical indications. The inclusion criteria are age over 18; chronic heart failure with reduced left ventricular systolic function (FE ≤ 45%), symptomatic (class NYHA II or greater; class III or greater or II with episodes of acute decompensation for patients with FE 36-45%); presence of appropriate and optimized medical therapy (including beta-blockers and angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers or angiotensin-receptor neprylysin inhibitors and anti-aldosterone agents); narrow QRS (\<120 msec) or cardiac resynchronization therapy non-responders; written informed consent for enrollment and participation in the prospective register; life expectancy\> 1 year due to the absence of non-cardiac comorbidities that reduce its prognosis; availability of venous access that can be used for the implant. The exclusion criteria are the absence of venous access available for the implant; contraindication to the interventional CCM implant procedure; life expectancy of less than one year due to non-cardiovascular comorbidities.

The aim of this multicenter, prospective, observational registry is to investigate the impact of CCM on the medium and long-term on clinical and functional characteristics of the enrolled patients at the end of the follow-up, with respect to the baseline value: NYHA class, 6-minute walk test, ejection fraction and volumes of the left ventricle, quality of life expressed through a specific questionnaire (Minnesota Living With Heart Failure Questionnaire, MLWHF), hospitalizations for heart failure or progression of the underlying heart disease. In addition, the survival of patients undergoing CCM device implantation will be assessed in an observational manner at 24 months and then annually.

In addition, adverse events related to the device implantation procedure or to CCM therapy are collected in the registry as a safety parameter. In the case of patients undergoing heart transplantation or LVAD implantation, or in the event of interruption of therapy or explantation of a device, the information will be recorded with the motivation for discontinuing treatment.

Clinical follow-up includes follow-up assessments at 3 months, 6 months, 12 months and every 6 months thereafter. Each clinical follow-up visit includes objective examination, ECG, device function check, administration of an MLWHF quality of life questionnaire, a 6-minute walk test (or cardiopulmonary exercise test) and pharmacological therapy assessment and optimization. Furthermore, during the follow-up visits at 3 months, 12 months and every 12 months thereafter, a transthoracic echocardiogram and blood chemistry tests are scheduled.

This multicenter observational prospective registry therefore aims to assess the long-term clinical impact of CCM in patients suffering from symptomatic heart failure with moderately or severely impaired systolic function. In particular, it will allow to evaluate the impact on functional capacity, symptoms and quality of life, hospitalizations, survival and device-related complications, with the aim of defining the role of CCM therapy in management of patient with heart failure with reduced left ventricular systolic function.

Conditions

• Heart Failure

Interventions

DEVICE

CCM device implantation

CCM implantation involves the introduction of two active fixation stimulation leads, fixed on the interventricular septum, and connected to the CCM generator (Optimizer Smart IV, Impulse Dynamic, and any subsequent versions of the same device) inserted in the subcutaneous or submuscular pocket. The implantation is ususally performed using vascular access via right or left cephalic or subclavian vein. The CCM signal consists of 2-3 biphasic pulses lasting 10 msec (total duration of about 20 ms) with an amplitude between 4.0 and 7.5 V, delivered during the absolute refractory period of the ventricle, at a distance of 40 msec from ventricular sensing. The CCM device is compatible with other pacing and defibrillation devices already implanted in the patient; at the time of the implantation, the devices are checked in order to confirm the absence of interference between the devices. The patient is instructed to charge the device battery weekly.

Sponsors & Collaborators

• Ospedale Umberto I di Torino

  collaborator OTHER

• A.O.U. Città della Salute e della Scienza - Molinette Hospital

  collaborator OTHER

• Ospedale Cardinal Massaia

  collaborator OTHER

• Azienda Ospedaliero Universitaria Maggiore della Carita

  collaborator OTHER

• Azienda Ospedaliera S. Maria della Misericordia

  collaborator OTHER

• IRCCS Multimedica

  collaborator OTHER

• San Giovanni di Dio Hospital

  collaborator OTHER

• Monaldi Hospital

  collaborator OTHER

• Ospedale Miulli, Acquaviva delle Fonti

  collaborator UNKNOWN

• Ospedale San Bortolo di Vicenza

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  collaborator OTHER

• ASST Fatebenefratelli Sacco

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Azienda Ospedaliera Bolognini di Seriate Bergamo

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Ospedale Santa Croce-Carle Cuneo

  collaborator OTHER

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

  collaborator OTHER

• Martini Hospital, Turin, Italy

  collaborator OTHER

• Ospedale di Ariano Irpino

  collaborator UNKNOWN

• Ospedale di Borgomanero

  collaborator UNKNOWN

• ASL Verbano Cusio Ossola

  collaborator OTHER_GOV

• Policlinico Hospital

  collaborator OTHER

• Azienda Ospedaliero Universitaria di Cagliari

  collaborator OTHER

• Fatebenefratelli Hospital

  collaborator OTHER

• Centro Cuore Morgagni, Pedara

  collaborator UNKNOWN

• Santa Maria delle Grazie Hospital

  collaborator OTHER

• Ospedale di Gorizia

  collaborator UNKNOWN

• ASP Enna

  collaborator UNKNOWN

• Ospedale Garibaldi, Catania

  collaborator UNKNOWN

• Ospedali Riuniti Anzio-Nettuno

  collaborator UNKNOWN

• Ospedale Fracastoro, Soave San Bonifacio

  collaborator UNKNOWN

• Ospedale Magalini, Villafranca

  collaborator UNKNOWN

• Casa di Cura Pierangeli, Pescara

  collaborator UNKNOWN

• S. Andrea Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2021-09-01

Completion

2023-09-01

Countries

• Italy

Study Locations