INGEVITY™ Observational Trial

NCT02166606 | Completed Results

• 1 other identifier: GENTLE-1013
• Study Type: observational
• Target: 1,184
• Locations: 13 countries
• Sites: 60

Brief Summary

The objectives of this registry are to

1. 1.Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
2. 2.Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
3. 3.Collect physician feedback on lead handling with the INGEVITY lead

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• Percentage of Leads Free From Complication

  Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.

  91 calendar days post-implant

Other Outcomes (1)

• MRI Procedures Through 12 Months Post-Implant

  365 calendar days post implant

Study Arms (1)

Pacemaker/Lead implant

All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an "all-comers" consecutive basis.

Device: ImageReady MR Conditional Pacing System Implant

Interventions

ImageReady MR Conditional Pacing System Implant DEVICE

Implant according to standard-of-care. No study-specific interventions in that registry.

Pacemaker/Lead implant

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

The subjects will be coming from the general patient population of the participating centers who are indicated for implantation of a BSC (Boston Scientific) ImageReady Pacing System (pulse generator \[PG\] \& leads) and who are fulfilling all inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Subject is willing and capable of providing informed consent and to give approval to collect / store / process personal health information by the sponsor
• Subject is scheduled for, or implanted with, a clinically indicated BSC ImageReady system according to current and locally applicable implant guidelines such as published by European Society of Cardiology (ESC) / American Heart Association (AHA) / American College of Cardiology (ACC) / Hearth Rhythm Society (HRS)
• Subject is geographically stable to be available for follow up at an approved registry center during the whole registry duration
• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

• Existing contraindications for a BSC ImageReady system as mentioned in the applicable reference guides of the implanted system components including a known or suspected sensitivity to dexamethasone acetate (DXA)
• Implanted pacing system is not ImageReady, i.e. any system components other than BSC INGEVITY MRI Conditional leads (or their market released successors), BSC INGENIO MRI family pacemaker models and their accessories (or their market released successors) intended to have MR Conditional status, including pre-existing abandoned leads of any kind still implanted and which will not be removed during the implant or re-implant procedure or plugged lead ports
• Any existing conditions per local standard of care preventing the subject from undergoing an MRI procedure including implanted active or inactive medical devices / material, not considered MR Conditional
• Subject is enrolled in any other concurrent study with the exception of local mandatory governmental registries and studies/registries that are not in conflict and do not affect the following:
• GENTLE registry outcome (i.e. involve different implantable system components than required for participation in GENTLE or would affect ability to undergo MRI procedures);
• Conduct of the GENTLE Registry per Good Clinical Practice (GCP)/ ISO (International Organization of Harmonization) 14155:2011/ local regulations as applicable
• Subject is a woman of childbearing potential who is, or might be, pregnant at the time of registry enrollment or plans to become pregnant during the course of the registry (based on physician's assessment)
• Estimated life expectancy of less than twelve months per physician discretion

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (60)

Medizinische Universitat Graz

Graz, 8036, Austria

Location

AKh - Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, 4021, Austria

Location

Ziekenhaus Oost Limburg

Genk, 3600, Belgium

Location

Grand Hopital De Charleroi

Gilly, 6060, Belgium

Location

Jessa Hospital

Hasselt, 3500, Belgium

Location

UCL de Mont Godinne

Yvoir, 5530, Belgium

Location

Clinique Rhone Durance

Avignon, 84000, France

Location

Hopital Prive Saint Martin

Caen, 14000, France

Location

Centre Hospitalier du Contentin

Cherbourg, 50100, France

Location

Centre Hospitalier de Marne La Vallee

Jossigny, 77600, France

Location

Hopital Saint Philibert

Lomme, 59462, France

Location

Hopital Prive Jacques Cartier

Massy, 91300, France

Location

Clinique Les Fontaines

Melun, 77000, France

Location

Centre Hospitalier de Moulins

Moulins, 3000, France

Location

Le Confluent - Nouvelles Cliniques Nantaises

Nantes, 44277, France

Location

Hopital Regional Orleans La Source

Orléans, 45000, France

Location

Groupement Hospitalier Pitie Salpetriere

Paris, 75013, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Centre Hospitalier de Saintonge

Saintes, 17108, France

Location

Clinique Saint Gatien

Tours, 37000, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

Charite, Universitatsmedizin Berlin, Campus Benjamin Franklin, Klinik fur Kardiologie und Pulmologie

Berlin, 12203, Germany

Location

Unfallkrankenhaus Berlin, Klinik fur Innere Medizin

Berlin, 12687, Germany

Location

Immanuel Klinikum Bernau/Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Universitatsklinikum Dusseldorf, Klinik fur Kardiovaskulare Chrirurgie

Düsseldorf, 40225, Germany

Location

Cardioangiologisches Centre Bethanien

Frankfurt, 60389, Germany

Location

Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem

Göttingen, 37073, Germany

Location

St. Marienkrankenhaus Siegen

Siegen, 57072, Germany

Location

University Hospital Galway

Galway, Ireland

Location

Bon Secours Hospital

Tralee, Ireland

Location

Fondazione Poliambulanza

Brescia, 25131, Italy

Location

Ospedale Annunziata

Cosenza, 87010, Italy

Location

Ospedale Spaziani Frosinone

Frosinone, 03100, Italy

Location

Ospedale Guzzardi di Vittoria

Ragusa, 00932, Italy

Location

Policlinico Casilino

Roma, 00169, Italy

Location

Azienda ULSS 9 Treviso

Treviso, 31100, Italy

Location

Ospedale Borgo Trento

Verona, 37126, Italy

Location

Akershus Universitetssykehus HF

Lorenskog, 1478, Norway

Location

Hospital Professor Doutor Fernando Fonseca, EPE

Amadora, 2720-276, Portugal

Location

Centro Hospitalar do Alto Ave, EPE

Guimarães, 4835-044, Portugal

Location

CHLO, EPE, Hospital S. Francisco Xavier

Lisbon, 1449-005, Portugal

Location

CHLN, EPE Hospital de Santa Maria

Lisbon, 1649-028, Portugal

Location

Hospital dos SAMS

Lisbon, 1849-017, Portugal

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463707, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 100744, South Korea

Location

Yonsei University Severance Hospital

Seoul, 120752, South Korea

Location

Samsung Medical Center

Seoul, 135710, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital de Merida

Mérida, 06800, Spain

Location

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Clinico Universitario Valladolid

Valladolid, 47011, Spain

Location

Hospital Virgen de la Concha

Zamora, 49022, Spain

Location

Skanes Universitetssjukhus

Lund, 22185, Sweden

Location

St Gorans Sjukhus

Stockholm, 11219, Sweden

Location

Universitatsspital Basel

Basel, 4031, Switzerland

Location

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dipl.-Ing. (FH) Jens Goetzke
• Organization: Boston Scientific

jens.goetzke@bsci.com

+49171

Study Officials

• Daniel Gras, MD

  Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 France

  PRINCIPAL INVESTIGATOR

• John doe, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: June 18, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 30, 2021
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

ES (8); SE (2); IE (2); CH (1); GB (1); FR (15); IT (7); DE (7); NO (1); AU (2); BE (4); PT (5); KR (5)