Congestive Heart FailureNICaS-CRTNCT02126241
Non-Invasive Cardiac Output Measurement for CRT Optimization
A study testing NICaS guided CRT optimization in people with Congestive Heart Failure, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This proposal aims to evaluate the added clinical and echocardiographic benefit of using the non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT recipients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- NICaS guided CRT optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients implanted with a CRT device at least 6 months before, in concordance with AHA/ACC or ESC/EHRA Guidelines (Class I or II) for CRT implantation
- NYHA class I - III heart failure
- Stable sinus rhythm
- Bi-ventricular pacing ≥ 90%
- Patient provides informed consent.
Who cannot join
- NYHA class IV heart failure
- Permanent or persistent atrial fibrillation
- Bi-ventricular pacing <90%
- Inability to perform the six-minute walk test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Impedance-Based Non-invasive Cardiac Output Measurement (NICaS) for Optimizing Cardiac Resynchronization Therapy: a Pilot Clinical Trial.
This proposal aims to evaluate the added clinical and echocardiographic benefit of using the non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT recipients.
Read the detailed description
- Introduction Cardiac resynchronization therapy (CRT) is an efficient treatment in heart failure (HF) patients with left ventricular (LV) systolic dysfunction and wide QRS. It is associated with improved exercise capacity, quality of life and left ventricular ejection fraction, as well as reverse remodeling, mitral regurgitation reduction, and mortality reduction. Predicting response to CRT is important as 30% of patients have no or minimal clinical improvement following CRT. Several parameters have been shown to influence response following implantation. Some relate to patients' characteristics including underlying heart disease, comorbidities and arrhythmias, type and severity of conduction disorder, presence and degree of dyssynchrony, presence and extent of scar tissue and functional myocardial reserve. Others are associated with technical aspects, including electrical and anatomical positioning of LV lead, programming mode and percentage of effective bi-ventricular pacing. Optimization of the atrio-ventricular (AV) delay and inter-ventricular (VV) delays can be used for maximizing CRT benefit, but is not routinely recommended by current guidelines. Standard optimization is performed under echocardiography guidance - a time and resource consuming method. Other non-invasive methods, such as impedance cardiography, can be used for AV delay optimization.
- Rationale for CRT optimization using NICaS The non-invasive cardiac system (NICaS) is a whole-body bioimpedance measurement method allowing real-time cardiac output (CO) assessment. It has been FDA approved for assisting in the diagnosis, monitoring and care management of patients with congestive heart failure as well as for cardiac pacemaker optimization. Clinical trials have shown its utility for the follow-up of outpatient monitoring chronic heart failure, for monitoring patients with heart failure and pulmonary hypertension. NICaS is sensitive enough for detecting real-time small changes in CO. Based on NICaS measured CO changes following AV and VV delays modifications, small series support its use for CRT optimization in a clinical setting, suggesting it may be associated with a reduction in non-responder rate.
- Hypothesis We hypothesize that the use of NICaS for optimization of AV and VV delays in chronic (more than 6 months) CRT recipients may result in an added clinical and echocardiographic benefit.
- Specific Aims
- Identify the CRT recipients who are prone to benefit following CRT optimization, by finding the predictors (clinical, ECG, echocardiographic, hemodynamic) for significant cardiac output improvement after NICaS guided CRT optimization
- Correlate the degree of cardiac output improvement (as measured by NICaS) after NICaS guided CRT optimization, with clinical and echocardiographic changes at 6 months
- Timeline:
- At Inclusion
I.A. Baseline assessment. Patients included in the study will benefit from the following at baseline assessment, performed in an outpatient setting:
- Clinical evaluation:
- history;
- NYHA class; six-minute walk test (6MWT); Minnesota Living with Heart Failure questionnaire for the quality of life (QoL);
- status following CRT (responder/non-responder);
- physical evaluation;
- current medication
- ECG
- Device interrogation
- Transthoracic echocardiography (including dyssynchrony parameters)
I.B. NICaS protocol for optimal AV and VV delays assessment. After baseline assessment is completed, patients will benefit from NICaS hemodynamic assessment and CRT programming according to NICaS guided optimal AV and VV delays. (for NICaS protocol for optimal AV and VV delays measurements - see Interventions)
I.C. After NICaS guided CRT programming, patients will perform a 6MWT
II. At 6 months follow-up. At 6 months, patients will benefit from the following evaluations:
- Clinical: NYHA class, 6MWT, Minnesota Living with Heart Failure questionnaire for the quality of life, current medication
- ECG
- Device interrogation
- Transthoracic echocardiography
- Conditions
- Congestive Heart Failure
- Being tested
- NICaS guided CRT optimization
- Keywords
- Heart Failure, Cardiac Resyncronization Therapy, Optimization, Non-invasive cardiac system, Impedance measured cardiac output
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICaS guided CRT optimizationOther
- Baseline CO measurement by NICaS
- AV delay optimization:
- AV delay will be changed (increase and decrease) by 30 ms steps , and for each new AV value, the CO will be real-time measured by NICaS
- The AV delay yielding the maximal CO, will be considered the optimal AV delay
- The device will be programmed using the optimal AV delay
- VV delay optimization:
- After Step 2, the baseline VV delay will be changed (increase and decrease; meaning that we will be pacing alternatively the LV before the RV, then the RV before the LV), by 30 ms steps, and for each new VV value, the CO will be real-time measured by NICaS
- The VV delay yielding the maximal CO, will be considered the optimal VV delay
- The device will be programmed using the optimal VV delay
| Study group | Role | What they receive |
|---|---|---|
| NICaS guided CRT optimization | Experimental | For each subject, we will determine a set of AV and VV delays values, for which the NICaS measured CO will be maximum. In each patient, the CRT device will then be programmed according to these values. Receives: Other: NICaS guided CRT optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors for significant cardiac output improvement
Using logistic regression, we will look for predictors (clinical, ECG, echocardiographic, hemodynamic) of significant (at least 20%) acute cardiac output improvement (as assessed by NICaS), after NICaS guided AV and VV delays optimization.
Measured: Within the first year after beginning of study
Secondary outcomes (5)
Acute six-minute walk test changes after NICaS optimization
After NICaS guided AV and VV delays optimization, each patient will perform a six-minute walk test, which will be compared to the baseline (before NICaS optimization) six-minute walk test. A 10% change will be considered significant.
Measured: Within the first 24 hours after enrollment
Reverse remodeling
Each patient will undergo routinely a 6-month echocardiography which will be compared to the baseline (inclusion day) echocardiography. A relative reduction of 10% of the left ventricular end-systolic volume will be considered as positive reverse remodeling.
Measured: At 6 months after enrollment
Hospitalization rate for heart failure
Hospitalization rate for acute heart failure during the first 6 months following NICaS guided CRT optimization
Measured: Within the first 6 months after enrollment
Supraventricular arrhythmia occurrence
CRT device measurement of the total time spent in auto-mode switch during the first 6 months following NICaS guided CRT optimization, and comparison to the 6 months prior to the optimization.
Measured: At 6 months after enrollment
Clinical improvement
Clinical improvement at 6 months after CRT optimization will be assessed using a composite score combining NYHA class, QoL and the 6MWT.
Each will be classified as improved (+1), stable (0) or worsened (-1) and the three components will be summed. The patient will be considered improved if he will have had ≥1 class reduction in his NYHA class, worsened if he will have had ≥1 class increase and unchanged if he will have had no change in his baseline NYHA class. Similar definitions will be used for absolute variation (improvement or deterioration) of 10 points in QoL, or relative 10%change in six-minute walk distance.
A clinical improvement will be considered in the presence of a summed score ≥+1 without death during the first 6 months of follow-up after CRT optimization.
Measured: At 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Glikson, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126241
- Sponsor's protocol ID
- SHEBA-1176-14-MG-CTIL
- Acronym
- NICaS-CRT
- Status last verified
- Aug 2015
- First submitted
- 27 Apr 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
PubMed 23801822Delnoy PP, Ritter P, Naegele H, Orazi S, Szwed H, Zupan I, Goscinska-Bis K, Anselme F, Martino M, Padeletti L. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study. Europace. 2013 Aug;15(8):1174-81. doi: 10.1093/europace/eut034. Epub 2013 Mar 14.
PubMed 23493410Tanino Y, Shite J, Paredes OL, Shinke T, Ogasawara D, Sawada T, Kawamori H, Miyoshi N, Kato H, Yoshino N, Hirata K. Whole body bioimpedance monitoring for outpatient chronic heart failure follow up. Circ J. 2009 Jun;73(6):1074-9. doi: 10.1253/circj.cj-08-0847. Epub 2009 Apr 16.
PubMed 19372625Heinroth KM, Elster M, Nuding S, Schlegel F, Christoph A, Carter J, Buerke M, Werdan K. Impedance cardiography: a useful and reliable tool in optimization of cardiac resynchronization devices. Europace. 2007 Sep;9(9):744-50. doi: 10.1093/europace/eum086. Epub 2007 May 11.
PubMed 17496288Turcott RG, Witteles RM, Wang PJ, Vagelos RH, Fowler MB, Ashley EA. Measurement precision in the optimization of cardiac resynchronization therapy. Circ Heart Fail. 2010 May;3(3):395-404. doi: 10.1161/CIRCHEARTFAILURE.109.900076. Epub 2010 Feb 22.
PubMed 20176716
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Impedance-Based Non-invasive Cardiac Output Measurement (NICaS) for Optimizing Cardiac Resynchronization Therapy: a Pilot Clinical Trial.
- ClinicalTrials.gov ID
- NCT02126241
- Acronym / sponsor ID
- NICaS-CRT / SHEBA-1176-14-MG-CTIL
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure, Cardiac Resyncronization Therapy, Optimization, Non-invasive cardiac system, Impedance measured cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal aims to evaluate the added clinical and echocardiographic benefit of using the non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT recipients.
Detailed description
- Introduction Cardiac resynchronization therapy (CRT) is an efficient treatment in heart failure (HF) patients with left ventricular (LV) systolic dysfunction and wide QRS. It is associated with improved exercise capacity, quality of life and left ventricular ejection fraction, as well as reverse remodeling, mitral regurgitation reduction, and mortality reduction. Predicting response to CRT is important as 30% of patients have no or minimal clinical improvement following CRT. Several parameters have been shown to influence response following implantation. Some relate to patients' characteristics including underlying heart disease, comorbidities and arrhythmias, type and severity of conduction disorder, presence and degree of dyssynchrony, presence and extent of scar tissue and functional myocardial reserve. Others are associated with technical aspects, including electrical and anatomical positioning of LV lead, programming mode and percentage of effective bi-ventricular pacing. Optimization of the atrio-ventricular (AV) delay and inter-ventricular (VV) delays can be used for maximizing CRT benefit, but is not routinely recommended by current guidelines. Standard optimization is performed under echocardiography guidance - a time and resource consuming method. Other non-invasive methods, such as impedance cardiography, can be used for AV delay optimization.
- Rationale for CRT optimization using NICaS The non-invasive cardiac system (NICaS) is a whole-body bioimpedance measurement method allowing real-time cardiac output (CO) assessment. It has been FDA approved for assisting in the diagnosis, monitoring and care management of patients with congestive heart failure as well as for cardiac pacemaker optimization. Clinical trials have shown its utility for the follow-up of outpatient monitoring chronic heart failure, for monitoring patients with heart failure and pulmonary hypertension. NICaS is sensitive enough for detecting real-time small changes in CO. Based on NICaS measured CO changes following AV and VV delays modifications, small series support its use for CRT optimization in a clinical setting, suggesting it may be associated with a reduction in non-responder rate.
- Hypothesis We hypothesize that the use of NICaS for optimization of AV and VV delays in chronic (more than 6 months) CRT recipients may result in an added clinical and echocardiographic benefit.
- Specific Aims
- Identify the CRT recipients who are prone to benefit following CRT optimization, by finding the predictors (clinical, ECG, echocardiographic, hemodynamic) for significant cardiac output improvement after NICaS guided CRT optimization
- Correlate the degree of cardiac output improvement (as measured by NICaS) after NICaS guided CRT optimization, with clinical and echocardiographic changes at 6 months
- Timeline:
- At Inclusion
I.A. Baseline assessment. Patients included in the study will benefit from the following at baseline assessment, performed in an outpatient setting:
- Clinical evaluation:
- history;
- NYHA class; six-minute walk test (6MWT); Minnesota Living with Heart Failure questionnaire for the quality of life (QoL);
- status following CRT (responder/non-responder);
- physical evaluation;
- current medication
- ECG
- Device interrogation
- Transthoracic echocardiography (including dyssynchrony parameters)
I.B. NICaS protocol for optimal AV and VV delays assessment. After baseline assessment is completed, patients will benefit from NICaS hemodynamic assessment and CRT programming according to NICaS guided optimal AV and VV delays. (for NICaS protocol for optimal AV and VV delays measurements - see Interventions)
I.C. After NICaS guided CRT programming, patients will perform a 6MWT
II. At 6 months follow-up. At 6 months, patients will benefit from the following evaluations:
- Clinical: NYHA class, 6MWT, Minnesota Living with Heart Failure questionnaire for the quality of life, current medication
- ECG
- Device interrogation
- Transthoracic echocardiography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICaS guided CRT optimization | Experimental | Other: NICaS guided CRT optimizationFor each subject, we will determine a set of AV and VV delays values, for which the NICaS measured CO will be maximum. In each patient, the CRT device will then be programmed according to these values. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients implanted with a CRT device at least 6 months before, in concordance with AHA/ACC or ESC/EHRA Guidelines (Class I or II) for CRT implantation
- NYHA class I - III heart failure
- Stable sinus rhythm
- Bi-ventricular pacing ≥ 90%
- Patient provides informed consent.
Key exclusion criteria (4 listed)
- NYHA class IV heart failure
- Permanent or persistent atrial fibrillation
- Bi-ventricular pacing <90%
- Inability to perform the six-minute walk test
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 |
|---|---|---|
| NICaS guided CRT optimization1. Baseline CO measurement by NICaS 2. AV delay optimization: 1. AV delay will be changed (increase and decrease) by 30 ms steps , and for each new AV value, the CO will be real-time measured by NICaS 2. The AV delay yielding the maximal CO, will be considered the optimal AV delay 3. The device will be programmed using the optimal AV delay 3. VV delay optimization: 1. After Step 2, the baseline VV delay will be changed (increase and decrease; meaning that we will be pacing alternatively the LV before the RV, then the RV before the LV), by 30 ms steps, and for each new VV value, the CO will be real-time measured by NICaS 2. The VV delay yielding the maximal CO, will be considered the optimal VV delay 3. The device will be programmed using the optimal VV delay | Other | NICaS guided CRT optimization |
Primary outcome
Predictors for significant cardiac output improvement
Time frame: Within the first year after beginning of study
Using logistic regression, we will look for predictors (clinical, ECG, echocardiographic, hemodynamic) of significant (at least 20%) acute cardiac output improvement (as assessed by NICaS), after NICaS guided AV and VV delays optimization.
5 secondary outcomes
Acute six-minute walk test changes after NICaS optimization
Time frame: Within the first 24 hours after enrollment
Reverse remodeling
Time frame: At 6 months after enrollment
Hospitalization rate for heart failure
Time frame: Within the first 6 months after enrollment
Supraventricular arrhythmia occurrence
Time frame: At 6 months after enrollment
Clinical improvement
Time frame: At 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Background: PubMed 23801822Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
- Background: PubMed 23493410Delnoy PP, Ritter P, Naegele H, Orazi S, Szwed H, Zupan I, Goscinska-Bis K, Anselme F, Martino M, Padeletti L. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study. Europace. 2013 Aug;15(8):1174-81. doi: 10.1093/europace/eut034. Epub 2013 Mar 14.
- Background: PubMed 19372625Tanino Y, Shite J, Paredes OL, Shinke T, Ogasawara D, Sawada T, Kawamori H, Miyoshi N, Kato H, Yoshino N, Hirata K. Whole body bioimpedance monitoring for outpatient chronic heart failure follow up. Circ J. 2009 Jun;73(6):1074-9. doi: 10.1253/circj.cj-08-0847. Epub 2009 Apr 16.
- Background: PubMed 17496288Heinroth KM, Elster M, Nuding S, Schlegel F, Christoph A, Carter J, Buerke M, Werdan K. Impedance cardiography: a useful and reliable tool in optimization of cardiac resynchronization devices. Europace. 2007 Sep;9(9):744-50. doi: 10.1093/europace/eum086. Epub 2007 May 11.
- Background: PubMed 20176716Turcott RG, Witteles RM, Wang PJ, Vagelos RH, Fowler MB, Ashley EA. Measurement precision in the optimization of cardiac resynchronization therapy. Circ Heart Fail. 2010 May;3(3):395-404. doi: 10.1161/CIRCHEARTFAILURE.109.900076. Epub 2010 Feb 22.
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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.
Michael Glikson, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICaS guided CRT optimization in people with Congestive Heart Failure, run by Sheba Medical Center at 1 site in Israel.
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 5 inclusion and 4 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictors for significant cardiac output improvement (time frame: Within the first year after beginning of study). 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 NCT02126241, which also lists 5 linked publications.
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 6 Aug 2015.