Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study (RallyX4)

Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4

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.

Study Overview

• Status: Completed
• Conditions: Heartfailure
• Intervention / Treatment: Device: Left Ventricular lead implant: ACUITY X4® Lead Family

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.

• Study Type: Observational
• Enrollment (Actual): 863

Contacts and Locations

Study Locations

• Austria
  • St.Pölten, Austria
    • Landesklinikum St.Pölten
• Belgium
  • Brussels, Belgium
    • Cliniques Universitaires Saint-Luc
  • Diegem, Belgium, 1831
    • Guidant Europe SA / NV a Boston Scientific Company
  • Gent, Belgium
    • Universitair Ziekenhuis Gent
• Colombia
  • Bogota, Colombia
    • Fundation Cardioinfantil
  • Cali, Colombia
    • Fundacion Valle del Lili
  • Medellin, Colombia
    • Clínica Medellín
• Denmark
  • Copenhagen, Denmark
    • Gentofte Hospital
  • Skejby, Denmark
    • Aarhus University Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
• France
  • Amiens, France
    • CHU Amiens
  • Annecy, France
    • Centre Hospitalier D'annecy
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrand
  • Grenoble, France
    • Chu de Grenoble
  • Lille, France
    • Centre Hospitalier Regional Universitaire de Lille
  • Marseille, France
    • Hopital De La Timone
  • Nantes, France
    • Nouvelles Cliniques Nantaises
  • Pau, France
    • Centre Hospitalier de Pau
  • Rennes, France
    • Chu de Rennes
  • Rouen, France
    • CH de Rouen
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Bad Oeynhausen, Germany
    • Herzzentrum Nordrhein-Westfalen
  • Berlin, Germany
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany
    • Unfallkrankenhaus Berlin
  • Gera, Germany
    • Waldklinikum Gera
  • Göttingen, Germany
    • Herz-und Gefäßzentrum Göttingen
  • Kassel, Germany
    • Klinikum Kassel
  • Landshut, Germany
    • Krankenhaus Landshut-Achdorf
  • Magdeburg, Germany
    • University Magdeburg
  • Oldenburg, Germany
    • Klinikum Oldenburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Ireland
  • Waterford, Ireland
    • Waterfort Hospital
• Israel
  • Ashkelon, Israel
    • Barzilai Medical Center
  • Petah Tikva, Israel
    • Beilinson medical center
  • Ramat Gan, Israel
    • Sheba Medical Center
  • Rechovot, Israel
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
• Italy
  • Bologna, Italy
    • Policlinico Sant'Orsola-Malpighi
  • Brescia, Italy
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Catania, Italy
    • Policlinico Vittorio Emanuele
  • Catanzaro, Italy
    • Ospedale Pugliese Ciaccio
  • Como, Italy
    • Azienda Ospedaliera Spedale Sant'Anna di Como
  • Mercogliano, Italy
    • Clinica Montevergine
  • Rovigo, Italy
    • Ospedale Santa Maria Misericordia
  • Verona, Italy
    • Ospedale Borgo Trento
• Japan
  • Amagasaki-Shi, Japan
    • Kansai Rosai Hospital
  • Isehara-Shi, Japan
    • Tokai University Hospital
  • Kamakura-Shi, Japan
    • Shonan Kamakura General Hospital
  • Kitakyushu-Shi, Japan
    • Kokura Memorial Hospital
  • Mitaka-Shi, Japan
    • Kyorin University Hospital
  • Osaka-Shi, Japan
    • Osaka General Medical Center
  • Osaka-Shi, Japan
    • Osaka Police Hospital
  • Osaka-Shi, Japan
    • Sakurabashi Watanabe Hospital
  • Sakai-Shi, Japan
    • Osaka Rosai Hospital
  • Suita-Shi, Japan
    • Osaka University Hospital
  • Yokohama-Shi, Japan
    • Yokohama City University Hospital
• Netherlands
  • Alkmaar, Netherlands
    • Medisch Centrum Alkmaar
  • Arnheim, Netherlands
    • Hospital Rijnstate
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Zwolle, Netherlands
    • Isala
• Portugal
  • Gaia, Portugal
    • Centro Hospitalar de Vila Nova de Gaia
  • Guimaraes, Portugal
    • Centro Hospitalar do Alto Ave
  • Lisbon, Portugal
    • Hospital Santa Maria
  • Lisbon, Portugal
    • Hospital Santa Cruz
  • Porto, Portugal
    • Centro Hospitalar do Porto
• Singapore
  • Singapore, Singapore
    • Changi General Hospital
  • Singapore, Singapore
    • National Heart Centre
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital Sant Pau
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain
    • Doce De Octubre University Hospital
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Toledo, Spain
    • Hospital Virgen de la Salud
  • Valladolid, Spain
    • Hospital Clínico Valladolid
• Switzerland
  • Geneva, Switzerland
    • Hopital Cantonal de Genève
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
  • St. Gallen, Switzerland
    • Institution Kantonsspital St. Gallen
• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elisabeth Hospital
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital
  • London, United Kingdom
    • St Bartholomew's Hospital
  • London, United Kingdom
    • Imperial College Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Subject is willing and capable of providing informed consent
2. 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
3. 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
4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate

2. 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
3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial

7. Subject's physician does not allow participation

   -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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' .

Device: Left Ventricular lead implant: ACUITY X4® Lead Family; Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment; Other Names: Autogen™X4 CRT-D G179-200 G177-200; Dynagen™ X4 CRT-D G158-200 G156-200; Inogen™ X4 CRT-D G148-200 G146-200; Origen™ X4 CRT-D G058-200 G056-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 Month Lead-related Complication-Free Rate (CFR)	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.	3 months post-implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 Month Implant Success Rate for Indicated Subjects	Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant.	3 months post-implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: ICON plc
• Investigators: Principal Investigator: Haran Burri, Prof., Hopital Cantonal de Genève; Study Chair: Torsten Kayser, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Phrenic Nerve Stimulation; Heartfailure treatment; CRT-D therapy; Quadripolar lead; Lead related complication free rate
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Rally X4-10-2013