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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01534234
Registration number
NCT01534234
Ethics application status
Date submitted
27/09/2011
Date registered
16/02/2012
Date last updated
11/01/2019
Titles & IDs
Public title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
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Scientific title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
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Secondary ID [1]
0
0
ITSY06 - RESPOND CRT
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Universal Trial Number (UTN)
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Trial acronym
RESPOND-CRT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure NYHA Class III and Ambulatory IV
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Devices - PARADYM RF SONR
Treatment: Devices - PARADYM RF SONR
Experimental: SonR group - SonR CRT Optimization
Active comparator: ECHO group - Echocardiographic Optimization
Treatment: Devices: PARADYM RF SONR
SonR CRT Optimization
Treatment: Devices: PARADYM RF SONR
Echocardiography Optimization
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Evaluation of SonR CRT Optimization Effectiveness in terms of proportion of responders at 12 months. The investigational(SonR)and control groups(ECHO)will be compared in a non-inferiority context employing a clinically meaningful difference of 10%.
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Assessment method [1]
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The analysis will be done on all patients implanted with the entire system who have been followed out to 12 months. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure (HF) events,New York Heart association(NYHA) class), Quality of life (QOL).
In the event that the non-inferiority test is met, a test of superiority will be conducted comparing the treatment and control groups.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months)
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Assessment method [2]
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SonRtip acute lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead within 3 months post-implant, relative to the total number of patients implanted with the lead.All patients who are successfully implanted with SonRtip lead will be included.
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Timepoint [2]
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3 months
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Primary outcome [3]
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Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months)
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Assessment method [3]
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SonRtip lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead from 3 to 12 months post-implant.All patients who are successfully implanted with SonRtip lead will be included.
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Timepoint [3]
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12 months
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Secondary outcome [1]
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Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months
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Assessment method [1]
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This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects that either died from any cause, or were hospitalized for heart failure
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months
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Assessment method [2]
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This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects classified as worsened, in order to evaluate the potential detrimental effects of the optimization method
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Timepoint [2]
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12 months
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Secondary outcome [3]
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SonR tip lead pacing threshold
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Assessment method [3]
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For all patients implanted with the SonRtip lead.
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Timepoint [3]
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24 months
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Secondary outcome [4]
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SonR tip lead sensing threshold
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Assessment method [4]
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For all patients implanted with the SonRtip lead.
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Timepoint [4]
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24 months
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Secondary outcome [5]
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SonR tip lead pacing impedance
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Assessment method [5]
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For all patients implanted with the SonRtip lead.
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
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Assessment method [6]
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The report of the deaths occurred consists of the percentage of dead patients, the causes of death, the time to death, the survival curves.
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Timepoint [6]
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24 months
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Secondary outcome [7]
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Report Heart Failure-related events to assess CRT effectiveness
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Assessment method [7]
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For all patients implanted it will be reported the percentage of patients with events, number of events for patients, event type, time to first occurence, survival curves)
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
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Assessment method [8]
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In all patients implanted the evaluation of the Quality of Life Score will consist of reporting the percentage of patients who showed improvement in their KCCQ Score at each follow-up post-implant
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
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Assessment method [9]
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In all patients implanted the evaluation of the NYHA Classification will consist of reporting the percentage of patients who improved at least one NYHA class at each follow-up post-implant
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12
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Assessment method [10]
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The intra-patient variations of the echocardiographic parameters measured at M12 as compared to those measured at baseline. The echo measures will be validated by an independent and blinded core lab
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
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Assessment method [11]
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The analysis will be done on all patients implanted with the entire system. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure events,NYHA class, Quality of life (QOL).
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Timepoint [11]
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18/24 months
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Secondary outcome [12]
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Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO)
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Assessment method [12]
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The amount of time (mean, median, standard deviation, minimum, maximum)in each group will be evaluated in all patients implanted
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Timepoint [12]
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24 months
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Secondary outcome [13]
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Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
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Assessment method [13]
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In all patients implanted will be evaluated the number of re-optimizations performed (mean, median, standard deviation, minimum, maximum) in each group (study and control).
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Timepoint [13]
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24 months
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Secondary outcome [14]
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Report Adverse Events for both group to assess CRT effectiveness / System Safety
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Assessment method [14]
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For all patients enrolled all Adverse Events will be reported.
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Timepoint [14]
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24 months
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Eligibility
Key inclusion criteria
1. Patient eligible with class I and IIa indication for implantation of a CRT-D device according to current available guidelines ;
2. Modere,Severe HF (NYHA Class III or ambulatory IV)
3. LVEF = 35 %
4. LBBB: QRS = 120 ms ; non-LBBB : QRS = 150 ms
5. On a stable, optimal drug regimen
6. Patient is in sinus rhythm at the time of enrollment;
7. Signed and dated informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
2. Incessant ventricular tachyarrhythmia;
3. Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks;
4. Correctable valvular disease that is the primary cause of heart failure;
5. Recent CVA or TIA (within the previous 3 months);
6. Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
7. Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
8. Renal failure (GFR<15 ml/min/1.73m2) or on dialysis
9. Previous implant with a CRT/CRT-D device;
10. Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices or RA leads should be removed prior to implant with the Paradym RF SONR CRT-D);
11. Already included in another clinical study that could confound the results of this study;
12. Life expectancy less than 1 year;
13. Inability to understand the purpose of the study or to understand and complete the QOL questionnaire;
14. Unavailability for scheduled follow-up or refusal to cooperate;
15. Sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
16. Age of less than 18 years;
17. Pregnancy
18. Drug addiction or abuse
19. Under guardianship
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2019
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Actual
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Sample size
Target
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Accrual to date
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Final
1039
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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4104 - Brisbane
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment outside Australia
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Alabama
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Austria
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Feldkirch
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Austria
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Innsbruck
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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MicroPort CRM
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Other
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Sorin CRM
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Summary
Brief summary
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software. This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method. This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.
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Trial website
https://clinicaltrials.gov/study/NCT01534234
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Trial related presentations / publications
Brugada J, Delnoy PP, Brachmann J, Reynolds D, Padeletti L, Noelker G, Kantipudi C, Rubin Lopez JM, Dichtl W, Borri-Brunetto A, Verhees L, Ritter P, Singh JP; RESPOND CRT Investigators. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7;38(10):730-738. doi: 10.1093/eurheartj/ehw526. Brugada J, Brachmann J, Delnoy PP, Padeletti L, Reynolds D, Ritter P, Borri-Brunetto A, Singh JP. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J. 2014 Apr;167(4):429-36. doi: 10.1016/j.ahj.2013.12.007. Epub 2013 Dec 19.
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Public notes
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Contacts
Principal investigator
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Josep Brugada
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Hospital Clinic of Barcelona
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Contact person for scientific queries
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What supporting documents are/will be available?
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Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT01534234
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