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

Heartfailure Clinical Trial

— RallyX4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066467
• Other study ID #: Rally X4-10-2013
• Status: Completed
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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 information / eligibility

• Status: Completed
• Enrollment: 863
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

-

Related Conditions & MeSH terms

• Heart Failure
• Heartfailure

Intervention

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

Locations

Country	Name	City	State
Austria	Landesklinikum St.Pölten	St.Pölten
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Guidant Europe SA / NV a Boston Scientific Company	Diegem
Belgium	Universitair Ziekenhuis Gent	Gent
Colombia	Fundation Cardioinfantil	Bogota
Colombia	Fundación Valle del Lili	Cali
Colombia	Clinica Medellin	Medellin
Denmark	Gentofte Hospital	Copenhagen
Denmark	Aarhus University Hospital	Skejby
Finland	Helsinki University Central Hospital	Helsinki
Finland	Oulu University Hospital	Oulu
France	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
Germany	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
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Ireland	Waterfort Hospital	Waterford
Israel	Barzilai Medical Center	Ashkelon
Israel	Beilinson Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Tel Aviv Medical Center	Tel Aviv
Italy	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
Japan	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-Shi
Japan	Osaka Police Hospital	Osaka-Shi
Japan	Sakurabashi Watanabe Hospital	Osaka-Shi
Japan	Osaka Rosai Hospital	Sakai-Shi
Japan	Osaka University Hospital	Suita-Shi
Japan	Yokohama City University Hospital	Yokohama-Shi
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Hospital Rijnstate	Arnheim
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Isala	Zwolle
Portugal	Centro Hospitalar de Vila Nova de Gaia	Gaia
Portugal	Centro Hospitalar do Alto Ave	Guimaraes
Portugal	Hospital Santa Cruz	Lisbon
Portugal	Hospital Santa Maria	Lisbon
Portugal	Centro Hospitalar do Porto	Porto
Singapore	Changi General Hospital	Singapore
Singapore	National Heart Centre	Singapore
Spain	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
Switzerland	Hôpital Cantonal de Genève	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Institution Kantonsspital St. Gallen	St. Gallen
United Kingdom	Queen Elisabeth Hospital	Birmingham
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Imperial College Healthcare	London
United Kingdom	St Bartholomew's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	ICON plc

Countries where clinical trial is conducted

Austria,  Belgium,  Colombia,  Denmark,  Finland,  France,  Germany,  Hong Kong,  Ireland,  Israel,  Italy,  Japan,  Netherlands,  Portugal,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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