Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
- Conditions
- Heartfailure
- Registration Number
- NCT02066467
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.
It is a prospective, non-randomized, observational multicenter study evaluating standard of care.
For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.
Study endpoints:
Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.
- Detailed Description
Clinic visits will occur at:
* Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure)
* Implant Procedure (Day 0; all future follow ups based on this date)
* Pre-Discharge Clinic Visit (≤ 7 days post implant procedure) (Required)
* One to 6 Month Clinic Visit (20 to 180 days post implant procedure) (Required)
* Interim Visit(s) (Any time between the 1 to 6 Month Clinic Visit and Close-out Clinic Visit) (Following study center specific standard of care) (Device follow up optional) AE - reporting required
* Close-out Clinic Visit (30 months ± 90 days, OR 180 days ± 90 days after the study is closed to enrollment, whichever comes first) (Required)
* During the trial all AEs, deaths, and changes in the device system must be reported
* Devices of subjects who have received a Latitude device will be followed by the Boston Scientific (BSC) Latitude team. Device Data as defined in the Clinical Investigation Plan (CIP), device alerts, and diagnostic data from the standard Latitude database may be collected and entered into the study database at any time.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 863
- Subject is willing and capable of providing informed consent
- Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator
- Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
-
Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
-
Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the RALLY X4 Study (i.e. should not cause additional or missed visits);
- RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
- Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable
-
Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
-
Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
-
Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
-
Subject does not anticipate being a resident of the area for the scheduled duration of the trial
-
Subject's physician does not allow participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phrenic Nerve Complication Free Rate 6 months post-implant The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold
- Secondary Outcome Measures
Name Time Method 3 Month Lead-related Complication-Free Rate (CFR) 3 months post-implant Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.
Trial Locations
- Locations (83)
CHU de Grenoble
🇫🇷Grenoble, France
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Waldklinikum Gera
🇩🇪Gera, Germany
Clinique Pasteur
🇫🇷Toulouse, France
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Kansai Rosai Hospital
🇯🇵Amagasaki-Shi, Japan
Centre Hospitalier de Pau
🇫🇷Pau, France
Klinikum Kassel
🇩🇪Kassel, Germany
Krankenhaus Landshut-Achdorf
🇩🇪Landshut, Germany
University Magdeburg
🇩🇪Magdeburg, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Centre Hospitalier Régional Universitaire de Lille
🇫🇷Lille, France
Hôpital de la Timone
🇫🇷Marseille, France
Herzzentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
Clinica Montevergine
🇮🇹Mercogliano, Italy
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
CHU de Rennes
🇫🇷Rennes, France
CH de Rouen
🇫🇷Rouen, France
Herz-und Gefäßzentrum Göttingen
🇩🇪Göttingen, Germany
Hospital Santa Cruz
🇵🇹Lisbon, Portugal
Ospedale Borgo Trento
🇮🇹Verona, Italy
Queen Elisabeth Hospital
🇬🇧Birmingham, United Kingdom
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Vírgen de la Salud
🇪🇸Toledo, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Changi General Hospital
🇸🇬Singapore, Singapore
Hospital Clinico Valladolid
🇪🇸Valladolid, Spain
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Imperial College Healthcare
🇬🇧London, United Kingdom
Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Ospedale Pugliese Ciaccio
🇮🇹Catanzaro, Italy
Azienda Ospedaliera Spedale Sant'Anna di Como
🇮🇹Como, Italy
Ospedale Santa Maria Misericordia
🇮🇹Rovigo, Italy
Landesklinikum St.Pölten
🇦🇹St.Pölten, Austria
Guidant Europe SA / NV a Boston Scientific Company
🇧🇪Diegem, Belgium
Gentofte Hospital
🇩🇰Copenhagen, Denmark
Aarhus University Hospital
🇩🇰Skejby, Denmark
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Doce De Octubre University Hospital
🇪🇸Madrid, Spain
CHU Amiens
🇫🇷Amiens, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Waterfort Hospital
🇮🇪Waterford, Ireland
Kyorin University Hospital
🇯🇵Mitaka-Shi, Japan
Hospital Rijnstate
🇳🇱Arnheim, Netherlands
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Beilinson Medical Center
🇮🇱Petah Tikva, Israel
Osaka Police Hospital
🇯🇵Osaka-Shi, Japan
Sakurabashi Watanabe Hospital
🇯🇵Osaka-Shi, Japan
Fundación Valle del Lili
🇨🇴Cali, Colombia
Clinica Medellin
🇨🇴Medellin, Colombia
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Fundation Cardioinfantil
🇨🇴Bogota, Colombia
Isala
🇳🇱Zwolle, Netherlands
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Shonan Kamakura General Hospital
🇯🇵Kamakura-Shi, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu-Shi, Japan
Kaplan Medical Center
🇮🇱Rechovot, Israel
Tokai University Hospital
🇯🇵Isehara-Shi, Japan
Osaka University Hospital
🇯🇵Suita-Shi, Japan
Yokohama City University Hospital
🇯🇵Yokohama-Shi, Japan
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Osaka General Medical Center
🇯🇵Osaka-Shi, Japan
Osaka Rosai Hospital
🇯🇵Sakai-Shi, Japan
Hôpital Cantonal de Genève
🇨🇭Geneva, Switzerland
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Centro Hospitalar do Alto Ave
🇵🇹Guimaraes, Portugal
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Gaia, Portugal
National Heart Centre
🇸🇬Singapore, Singapore
Institution Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong