HeartfailureRallyX4NCT02066467

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

An observational study of Heartfailure, run by Boston Scientific Corporation at 83 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Heartfailure
What is being tested?: Left Ventricular lead implant: ACUITY X4® Lead Family
Type of treatment: Injection or infusion, Medical device
How many people: 863 participants
Where: 83 sitesin 18 countries
Study dates: Feb 2014to Sep 2016
How long will I take part?: 12 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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
-

Trial locations and contacts

83 sites in 18 countries.

Country

City, postcode or hospital

83 sites in 18 countries

France11 sites

CHU Amiens
Amiens
Centre Hospitalier d'Annecy
Annecy
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Grenoble
Grenoble
Centre Hospitalier Régional Universitaire de Lille
Lille
Hôpital de la Timone
Marseille
Nouvelles Cliniques Nantaises
Nantes
Centre Hospitalier de Pau
Pau
CHU de Rennes
Rennes
CH de Rouen
Rouen
Clinique Pasteur
Toulouse

Other trials in France

Japan11 sites

Kansai Rosai Hospital
Amagasaki-Shi
Tokai University Hospital
Isehara-Shi
Shonan Kamakura General Hospital
Kamakura-Shi
Kokura Memorial Hospital
Kitakyushu-Shi
Kyorin University Hospital
Mitaka-Shi
Osaka General Medical Center
Osaka
Osaka Police Hospital
Osaka
Sakurabashi Watanabe Hospital
Osaka
Osaka Rosai Hospital
Sakaishi
Osaka University Hospital
Suita-Shi
Yokohama City University Hospital
Yokohama

Other trials in Japan

Germany9 sites

Herzzentrum Nordrhein-Westfalen
Bad Oeynhausen
Deutsches Herzzentrum Berlin
Berlin
Unfallkrankenhaus Berlin
Berlin
Waldklinikum Gera
Gera
Herz-und Gefäßzentrum Göttingen
Göttingen
Klinikum Kassel
Kassel
Krankenhaus Landshut-Achdorf
Landshut
University Magdeburg
Magdeburg
Klinikum Oldenburg
Oldenburg

Other trials in Germany

Italy8 sites

Policlinico Sant'Orsola-Malpighi
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
Policlinico Vittorio Emanuele
Catania
Ospedale Pugliese Ciaccio
Catanzaro
Azienda Ospedaliera Spedale Sant'Anna di Como
Como
Clinica Montevergine
Mercogliano
Ospedale Santa Maria Misericordia
Rovigo
Ospedale Borgo Trento
Verona

Other trials in Italy

Spain7 sites

Hospital Clinic de Barcelona
Barcelona
Hospital Sant Pau
Barcelona
Doce De Octubre University Hospital
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Clínica Universidad de Navarra
Pamplona
Hospital Vírgen de la Salud
Toledo
Hospital Clinico Valladolid
Valladolid

Other trials in Spain

Israel5 sites

Barzilai Medical Center
Ashkelon
Beilinson Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Tel Aviv Medical Center
Tel Aviv

Other trials in Israel

Portugal5 sites

Centro Hospitalar de Vila Nova de Gaia
Gaia
Centro Hospitalar do Alto Ave
Guimarães
Hospital Santa Cruz
Lisbon
Hospital Santa Maria
Lisbon
Centro Hospitalar do Porto
Porto

Other trials in Portugal

Netherlands4 sites

Medisch Centrum Alkmaar
Alkmaar
Hospital Rijnstate
Arnhem
Medisch Spectrum Twente
Enschede
Isala
Zwolle

Other trials in Netherlands

United Kingdom4 sites

Queen Elisabeth Hospital
Birmingham
Golden Jubilee National Hospital
Glasgow
Imperial College Healthcare
London
St Bartholomew's Hospital
London

Other trials in United Kingdom

Belgium3 sites

Cliniques Universitaires Saint-Luc
Brussels
Guidant Europe SA / NV a Boston Scientific Company
Diegem, 1831
Universitair Ziekenhuis Gent
Ghent

Other trials in Belgium

Colombia3 sites

Fundation Cardioinfantil
Bogotá
Fundación Valle del Lili
Cali
Clinica Medellin
Medellín

Other trials in Colombia

Switzerland3 sites

Hôpital Cantonal de Genève
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
Institution Kantonsspital St. Gallen
Sankt Gallen

Other trials in Switzerland

Denmark2 sites

Gentofte Hospital
Copenhagen
Aarhus University Hospital
Skejby

Other trials in Denmark

Finland2 sites

Helsinki University Central Hospital
Helsinki
Oulu University Hospital
Oulu

Other trials in Finland

Hong Kong2 sites

Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong

Other trials in Hong Kong

Singapore2 sites

Changi General Hospital
Singapore
National Heart Centre
Singapore

Other trials in Singapore

Austria1 site

Landesklinikum St.Pölten
Sankt Pölten

Other trials in Austria

Ireland1 site

Waterfort Hospital
Waterford

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Conditions: Heartfailure
Being tested: Left Ventricular lead implant: ACUITY X4® Lead Family
Keywords: Phrenic Nerve Stimulation, Heartfailure treatment, CRT-D therapy, Quadripolar lead, Lead related complication free rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Left Ventricular lead implant: ACUITY X4® Lead FamilyDevice
Also called 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
Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment

Study groups in NCT02066467
Study group	Role	What they receive
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' . Receives: Device: Left Ventricular lead implant: ACUITY X4® Lead Family

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months post-implant

Secondary outcomes (1)

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.
Measured: 3 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Sep 2016

First posted19 Feb 2014 (estimated)
Study startFeb 2014
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HeartfailureStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 863 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT02066467
Sponsor's protocol ID: Rally X4-10-2013
Acronym: RallyX4
Status last verified: Aug 2019
First submitted: 7 Feb 2014
Last updated: 20 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4
ClinicalTrials.gov ID: NCT02066467
Acronym / sponsor ID: RallyX4 / Rally X4-10-2013
Conditions: Heartfailure
Keywords: Phrenic Nerve Stimulation, Heartfailure treatment, CRT-D therapy, Quadripolar lead, Lead related complication free rate
Study type: Observational
Recruitment status: Completed
Enrolment: 863 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Collaborators: ICON plc
Study start: Feb 2014 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 19 Feb 2014 (estimated)
Results: Posted 20 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study endpoints:

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 design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Heart failure patients	–	Device: Left Ventricular lead implant: ACUITY X4® Lead Family* 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' .

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Left Ventricular lead implant: ACUITY X4® Lead FamilyAlso: 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 G056-200Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment	Device	Heart failure patients

Primary outcome

Phrenic Nerve Complication Free Rate
Time frame: 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

1 secondary outcome

3 Month Lead-related Complication-Free Rate (CFR)
Time frame: 3 months post-implant

Results and safety

Results posted to the registry on 20 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Heart Failure Patients	863	648

Primary outcome: Phrenic Nerve Complication Free Rate

Time frame: 6 months post-implant. Number (90% Confidence Interval). Unit: % of participants

Measure	Heart Failure Patients n = 795
Value	99.5 (98.8 to 99.8)

Heart Failure Patients: p <0.0001, exact binominal methodology

Population analysed: 795 patients successfully implanted with ACUITY X4 lead

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Heart Failure Patients	338 of 838 (40.3%)	452 of 838 (53.9%)	54 of 838

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haran Burri, Prof. principal investigator

Hôpital Cantonal de Genève

Torsten Kayser study chair

Boston Scientific Corporation

83 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heartfailure, run by Boston Scientific Corporation at 83 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in France, Japan, Germany, Italy, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phrenic Nerve Complication Free Rate (time frame: 6 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02066467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.