Clinical trial NCT04755569: Optimizer System With ODOCOR II CCM™ Leads
Official title: Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead
Lead sponsor: Impulse Dynamics
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.

Four hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe

Brief summary: The objective of the ODOCOR II CCM lead study is to evaluate the safety and useability of the ODOCOR II intra-cardiac lead specifically intended to deliver CCM as an accessory lead to the Optimizer IPG.

Detailed description: Design A prospective, multi-center, single arm open label study, 12-month study of 400 ODOCOR II CCM™ leads in 200 subjects .

Method Subjects shall be enrolled that have been diagnosed with NYHA Class III-IV heart failure and left ventricular ejection fraction (25-45% inclusive). Eligible subjects will receive the Optimizer IPG device implant with 2 ODOCOR II CCM leads. Subjects will return for follow-up visits at 2-weeks, 6 months and 12 months following the device implant.

Endpoints Primary Safety endpoint

The primary safety endpoint is the incidence of lead-related complication free rate at 12 months post-index implantation procedure compared to the incidence previously described in the literature for pacing therapy leads.

Secondary Safety endpoint

The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.

Primary Efficacy endpoint The total amount of CCM delivered to the cardiac tissue of the right ventricle (measured by CCM percentage) will be measured over a period of 12 months.

Secondary Efficacy endpoint Change in QOL, as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ), from baseline to 12 months following index implantation procedure.

Additional Endpoints Handling characteristics of the lead will be evaluated by the implanting physician. Ease of insertion, lead visibility on x-ray, and the ability to visualize the helix deployment will be assessed via a questionnaire administered at the completion of an implant procedure.

Patients, sites Four hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe.

Duration The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.

Eligibility criteria: Inclusion Criteria:

1. Patient signed and dated informed consent form
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive)
4. Diagnosed with NYHA Class III or IV heart failure
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Medically stable and with no significant mental illness in the judgement of the principal investigator

Exclusion Criteria:

1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor)
2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 3 months of the baseline testing visit.
3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before the baseline testing visit, including continuous IV inotrope therapy
4. Myocardial infarction within 3 months of the baseline testing visit.
5. Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 days of the baseline testing visit.
6. Undergone a cardiac ablation procedure within 90 days prior to consent.
7. Prior heart transplant or ventricular assist device
8. Mechanical tricuspid valve
9. Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
10. Currently on dialysis
11. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer
12. Participating in another cardiac investigational device study at the same time
13. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed content.
14. Expected lifespan of less than 12 months from time the baseline testing visit.
15. Resting heart rate \>110 bpm at the time of the baseline testing visit
16. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure

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Primary outcomes:
measure: Primary Safety endpoint
timeFrame: 12 months
measure: Primary Efficacy endpoint
timeFrame: 12 month
Secondary outcomes:
measure: Secondary Safety endpoint
timeFrame: 12 month
measure: Secondary Efficacy endpoint
timeFrame: 12 month
Other outcomes:
measure: Additional Endpoints
timeFrame: at implant
Locations:
city: Heilbronn
country: Germany
facility: Klinik am Plattenwald
state: Baden Wuerttemberg
city: Sulzbach-Rosenberg
country: Germany
facility: St. Anna Krankenhaus
state: Bavaria
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden GmbH
state: Hessen
city: Stade
country: Germany
facility: Elbe Klinikum Stade
state: Lower Saxony
city: Stadtlohn
country: Germany
facility: Krankenhaus Marie-Hilf Stadtlohn
state: North Rhine Westphalia
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum-Mitte
state: North Rhine-Westphalia
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
state: Saxony-Anhalt
city: Dresden
country: Germany
facility: Herzzentrum Dresden
state: Saxony
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Koepenick
city: Berlin
country: Germany
facility: Charité Berlin Campus Virchow
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel
city: Coburg
country: Germany
facility: Regiomed Kliniken-Coburg
city: Friedrichroda
country: Germany
facility: SRH Krankenhaus Waltershausen-Friedrichroda
city: Gelsenkirchen
country: Germany
facility: Marienhospital
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Schoen Klinik Hamburg Eilbek
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
city: Lünen
country: Germany
facility: St. Marien-Hospital Klinikum Luenen
city: Mannheim
country: Germany
facility: Universitaetsklinikum UMM
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH
city: Naples
country: Italy
facility: Azienda Ospedaliera Dei Colli-Monaldi
state: Campania
city: Erba
country: Italy
facility: Ospedale "Sacra Famiglia" - Fatebenefratelli dell'
state: Lombardo Veneta
city: Acquaviva Delle Fonti
country: Italy
facility: Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.
city: Ascoli Piceno
country: Italy
facility: Ospedale C. e G. "Mazzoni"
city: Bari
country: Italy
facility: Ospedale San Paolo, UOC Cardiologia ed UTIC
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera
city: Bologna
country: Italy
facility: IRCCS Policlinico Sant'Orsola-Malpighi
city: Cagliari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Castrovillari
country: Italy
facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari
city: Ciriè
country: Italy
facility: ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carita
city: Pescara
country: Italy
facility: Gruppo Synergo - Casa Di Cura Pierangeli
city: Vercelli
country: Italy
facility: Presidio Ospedaliero Sant'Andrea
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza - Azienda UlSS 8 Berica
city: Almería
country: Spain
facility: Complejo Hospitario Torrecardenas
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico U. de Santiago
Study officials:
affiliation: Monaldi Hospital
name: Stefano DeVivo, MD
role: PRINCIPAL_INVESTIGATOR
References: