Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
RallyX4
1 other identifier
observational
863
18 countries
83
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Typical duration for all trials
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
September 20, 2019
CompletedSeptember 20, 2019
August 1, 2019
2.6 years
February 7, 2014
August 14, 2018
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phrenic Nerve Complication Free Rate
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
6 months post-implant
Secondary Outcomes (1)
3 Month Lead-related Complication-Free Rate (CFR)
3 months post-implant
Other Outcomes (1)
3 Month Implant Success Rate for Indicated Subjects
3 months post-implant
Study Arms (1)
Heart failure patients
* Subjects with art failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .
Interventions
Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Eligibility Criteria
The BSC Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for subjects with art failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: * Moderate to severe heart failure (New York Heart Association (NYHA) Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure BSCCRT-Ds are also intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- ICON plccollaborator
Study Sites (83)
Landesklinikum St.Pölten
Sankt Pölten, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Guidant Europe SA / NV a Boston Scientific Company
Diegem, 1831, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Fundation Cardioinfantil
Bogotá, Colombia
Fundación Valle del Lili
Cali, Colombia
Clinica Medellin
Medellín, Colombia
Gentofte Hospital
Copenhagen, Denmark
Aarhus University Hospital
Skejby, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
CHU Amiens
Amiens, France
Centre Hospitalier d'Annecy
Annecy, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Grenoble
Grenoble, France
Centre Hospitalier Régional Universitaire de Lille
Lille, France
Hôpital de la Timone
Marseille, France
Nouvelles Cliniques Nantaises
Nantes, France
Centre Hospitalier de Pau
Pau, France
CHU de Rennes
Rennes, France
CH de Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
Herzzentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
Waldklinikum Gera
Gera, Germany
Herz-und Gefäßzentrum Göttingen
Göttingen, Germany
Klinikum Kassel
Kassel, Germany
Krankenhaus Landshut-Achdorf
Landshut, Germany
University Magdeburg
Magdeburg, Germany
Klinikum Oldenburg
Oldenburg, Germany
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Waterfort Hospital
Waterford, Ireland
Barzilai Medical Center
Ashkelon, Israel
Beilinson Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
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
Clinica Montevergine
Mercogliano, Italy
Ospedale Santa Maria Misericordia
Rovigo, Italy
Ospedale Borgo Trento
Verona, Italy
Kansai Rosai Hospital
Amagasaki-Shi, Japan
Tokai University Hospital
Isehara-Shi, Japan
Shonan Kamakura General Hospital
Kamakura-Shi, Japan
Kokura Memorial Hospital
Kitakyushu-Shi, Japan
Kyorin University Hospital
Mitaka-Shi, Japan
Osaka General Medical Center
Osaka, Japan
Osaka Police Hospital
Osaka, Japan
Sakurabashi Watanabe Hospital
Osaka, Japan
Osaka Rosai Hospital
Sakaishi, Japan
Osaka University Hospital
Suita-Shi, Japan
Yokohama City University Hospital
Yokohama, Japan
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Hospital Rijnstate
Arnhem, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Isala
Zwolle, Netherlands
Centro Hospitalar de Vila Nova de Gaia
Gaia, Portugal
Centro Hospitalar do Alto Ave
Guimarães, Portugal
Hospital Santa Cruz
Lisbon, Portugal
Hospital Santa Maria
Lisbon, Portugal
Centro Hospitalar do Porto
Porto, Portugal
Changi General Hospital
Singapore, Singapore
National Heart Centre
Singapore, Singapore
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Doce De Octubre University Hospital
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Vírgen de la Salud
Toledo, Spain
Hospital Clinico Valladolid
Valladolid, Spain
Hôpital Cantonal de Genève
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Institution Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Queen Elisabeth Hospital
Birmingham, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Imperial College Healthcare
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Results Point of Contact
- Title
- Caroline Beaudoint
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Haran Burri, Prof.
Hôpital Cantonal de Genève
- STUDY CHAIR
Torsten Kayser
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 19, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 20, 2019
Results First Posted
September 20, 2019
Record last verified: 2019-08