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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04595305




Registration number
NCT04595305
Ethics application status
Date submitted
2/08/2020
Date registered
20/10/2020

Titles & IDs
Public title
Septal Mapping And Resynchronisation Therapy- (SMART) Study
Scientific title
Septal Mapping And Resynchronisation Therapy- (SMART) Study
Secondary ID [1] 0 0
ABT-CIP-10291
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Resynchronization Therapy 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cardiac resynchronization therapy by CRT-P or CRT-D implantation

Other: Treatment Arm - Standard of Care - Implantation of CRT-P or CRT-D for a clinical indication as per standard of care.


Treatment: Devices: Cardiac resynchronization therapy by CRT-P or CRT-D implantation
Clinically indicated implantation of a CRT-P or CRT-D device as per standard of care
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quantification of activation times (ms) of the RV and LV septum
Timepoint [1] 0 0
During implant procedure
Secondary outcome [1] 0 0
Quantification of the correlation coefficient relating changes in end-systolic volume (%) to the following variables: septal activation time (ms), septal scarring (% area), and ECG QRS duration (ms).
Timepoint [1] 0 0
12 months post-implant

Eligibility
Key inclusion criteria
* Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law
* Subject must provide written informed consent prior to any clinical investigation related procedure
* Subjects who are undergoing implantation of an Abbott CRT-P or CRT-D device under standard indications
* Subjects are treated with optimal pharmacological therapy (as determined by the site principle investigator) for a minimum 4 weeks prior to procedure
* ECG showing Sinus Rhythm (SR)
* LBBB morphology with QRS duration >130ms
* Subject should be willing and able to comply with the prescribed follow-up schedule of evaluations.
* Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with a life expectancy less than the duration of the study
* Subjects with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
* Subjects with mechanical tricuspid or aortic heart valves
* Inaccessibility for follow-up at the study centre
* Unwillingness or inability to provide written informed consent
* Enrollment in, or intention to participate in, another clinical study during the course of this study excluding a registry
* Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2022
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Abbott Medical Australia Pty Ltd - Macquarie Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David O'Donnell, MD, FRACP
Address 0 0
Fundacion GenesisCare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04595305