Heart FailureCCI impactNCT01996397
Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
A study testing Cardiac resynchronization therapy device implantation in people with Heart Failure and Resynchronization Therapy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Resynchronization Therapy, Assessment of Acute CRT Response
- What is being tested?
- Cardiac resynchronization therapy device implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines
- Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
- Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
- Subject (or the legal guardian) is willing to sign informed consent form
Who cannot join
- Permanent atrial fibrillation/ flutter or tachycardia
- RBBB
- Recent myocardial infarction (MI), within 40 days prior to enrollment. Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
- Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
- On chronic renal dialysis, or with severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2)
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- On continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
- Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
- Complex and uncorrected congenital heart disease
- Mechanical heart valve
- Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- Enrolled in one or more concurrent studies that would confound the results of this study
- Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement
Trial locations and contacts
1 site in 1 country.
About this study
Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.
- Being tested
- Cardiac resynchronization therapy device implantation
- Keywords
- Heart failure, Bundle branch block, CRT response
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy device implantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CRT implantation | Other | Standard CRT indication. Assessment of acute response to CRT. Receives: Procedure: Cardiac resynchronization therapy device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
dP\dt max response to different ventricular lead pacing sites
To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site.
Measured: 6 months
Secondary outcomes (3)
Lead movements and electrical measures
Compare metrics derived from 2/3-D reconstructions of lead movement to electrical measures (e.g. Q-LV-timing or VCG) at different pacing configurations in patients undergoing a CRT-implant.
Measured: 6 months
Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation
To compare metrics derived from 2/3-D reconstructions of lead movement to Force-Interval-Relation at different pacing configurations in patients undergoing a CRT-implant.
Measured: 6 months
Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map
To compare metrics derived from 2/3-D reconstructions of lead movement to CardioGuide Motion Map at different pacing configurations in patients undergoing a CRT-implant.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Principal investigator, Erik Kongsgaard, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996397
- Sponsor's protocol ID
- 2013/140
- Acronym
- CCI impact
- Status last verified
- Mar 2016
- First submitted
- 1 Nov 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
PubMed 15152059Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
PubMed 15753115Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
PubMed 12063368Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, Leon AR, Oshinski JN. Agreement is poor among current criteria used to define response to cardiac resynchronization therapy. Circulation. 2010 May 11;121(18):1985-91. doi: 10.1161/CIRCULATIONAHA.109.910778. Epub 2010 Apr 26.
PubMed 20421518Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. doi: 10.1161/hc5001.102229.
PubMed 11748094Rossillo A, Verma A, Saad EB, Corrado A, Gasparini G, Marrouche NF, Golshayan AR, McCurdy R, Bhargava M, Khaykin Y, Burkhardt JD, Martin DO, Wilkoff BL, Saliba WI, Schweikert RA, Raviele A, Natale A. Impact of coronary sinus lead position on biventricular pacing: mortality and echocardiographic evaluation during long-term follow-up. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1120-5. doi: 10.1046/j.1540-8167.2004.04089.x.
PubMed 15485432Merchant FM, Heist EK, McCarty D, Kumar P, Das S, Blendea D, Ellinor PT, Mela T, Picard MH, Ruskin JN, Singh JP. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm. 2010 May;7(5):639-44. doi: 10.1016/j.hrthm.2010.01.035. Epub 2010 Feb 1.
PubMed 20298819Mullens W, Verga T, Grimm RA, Starling RC, Wilkoff BL, Tang WHW. Persistent hemodynamic benefits of cardiac resynchronization therapy with disease progression in advanced heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):600-607. doi: 10.1016/j.jacc.2008.08.079.
PubMed 19215835Blendea D, Singh JP. Lead positioning strategies to enhance response to cardiac resynchronization therapy. Heart Fail Rev. 2011 May;16(3):291-303. doi: 10.1007/s10741-010-9212-4.
PubMed 21184174Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.
PubMed 21884950Bogaard MD, Houthuizen P, Bracke FA, Doevendans PA, Prinzen FW, Meine M, van Gelder BM. Baseline left ventricular dP/dtmax rather than the acute improvement in dP/dtmax predicts clinical outcome in patients with cardiac resynchronization therapy. Eur J Heart Fail. 2011 Oct;13(10):1126-32. doi: 10.1093/eurjhf/hfr094. Epub 2011 Jul 26.
PubMed 21791536Butter C, Stellbrink C, Belalcazar A, Villalta D, Schlegl M, Sinha A, Cuesta F, Reister C. Cardiac resynchronization therapy optimization by finger plethysmography. Heart Rhythm. 2004 Nov;1(5):568-75. doi: 10.1016/j.hrthm.2004.07.002.
PubMed 15851221Whinnett ZI, Davies JE, Willson K, Chow AW, Foale RA, Davies DW, Hughes AD, Francis DP, Mayet J. Determination of optimal atrioventricular delay for cardiac resynchronization therapy using acute non-invasive blood pressure. Europace. 2006 May;8(5):358-66. doi: 10.1093/europace/eul017.
PubMed 16635996Whinnett ZI, Davies JE, Willson K, Manisty CH, Chow AW, Foale RA, Davies DW, Hughes AD, Mayet J, Francis DP. Haemodynamic effects of changes in atrioventricular and interventricular delay in cardiac resynchronisation therapy show a consistent pattern: analysis of shape, magnitude and relative importance of atrioventricular and interventricular delay. Heart. 2006 Nov;92(11):1628-34. doi: 10.1136/hrt.2005.080721. Epub 2006 May 18.
PubMed 16709698Bocchiardo M, Meyer zu Vilsendorf D, Militello C, Lippert M, Czygan G, Schauerte P, Gaita F, Stellbrink C. Resynchronization therapy optimization by intracardiac impedance. Europace. 2010 Nov;12(11):1589-95. doi: 10.1093/europace/euq273. Epub 2010 Jul 28.
PubMed 20667892
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01996397
- Acronym / sponsor ID
- CCI impact / 2013/140
- Keywords
- Heart failure, Bundle branch block, CRT response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- May 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Nov 2013 (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.
Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT implantation | Other | Procedure: Cardiac resynchronization therapy device implantationStandard CRT indication. Assessment of acute response to CRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines
- Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
- Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
- Subject (or the legal guardian) is willing to sign informed consent form
Key exclusion criteria (13 listed)
- Permanent atrial fibrillation/ flutter or tachycardia
- RBBB
- Recent myocardial infarction (MI), within 40 days prior to enrollment. Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
- Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
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 |
|---|---|---|
| Cardiac resynchronization therapy device implantation | Procedure or surgery | CRT implantation |
Primary outcome
dP\dt max response to different ventricular lead pacing sites
Time frame: 6 months
To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site.
3 secondary outcomes
Lead movements and electrical measures
Time frame: 6 months
Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation
Time frame: 6 months
Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map
Time frame: 6 months
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 31 Mar 2016.
- Background: PubMed 15152059Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
- Background: PubMed 15753115Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
- Background: PubMed 12063368Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
- Background: PubMed 20421518Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, Leon AR, Oshinski JN. Agreement is poor among current criteria used to define response to cardiac resynchronization therapy. Circulation. 2010 May 11;121(18):1985-91. doi: 10.1161/CIRCULATIONAHA.109.910778. Epub 2010 Apr 26.
- Background: PubMed 11748094Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. doi: 10.1161/hc5001.102229.
- Background: PubMed 15485432Rossillo A, Verma A, Saad EB, Corrado A, Gasparini G, Marrouche NF, Golshayan AR, McCurdy R, Bhargava M, Khaykin Y, Burkhardt JD, Martin DO, Wilkoff BL, Saliba WI, Schweikert RA, Raviele A, Natale A. Impact of coronary sinus lead position on biventricular pacing: mortality and echocardiographic evaluation during long-term follow-up. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1120-5. doi: 10.1046/j.1540-8167.2004.04089.x.
- Background: PubMed 20298819Merchant FM, Heist EK, McCarty D, Kumar P, Das S, Blendea D, Ellinor PT, Mela T, Picard MH, Ruskin JN, Singh JP. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm. 2010 May;7(5):639-44. doi: 10.1016/j.hrthm.2010.01.035. Epub 2010 Feb 1.
- Background: PubMed 19215835Mullens W, Verga T, Grimm RA, Starling RC, Wilkoff BL, Tang WHW. Persistent hemodynamic benefits of cardiac resynchronization therapy with disease progression in advanced heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):600-607. doi: 10.1016/j.jacc.2008.08.079.
- Background: PubMed 21184174Blendea D, Singh JP. Lead positioning strategies to enhance response to cardiac resynchronization therapy. Heart Fail Rev. 2011 May;16(3):291-303. doi: 10.1007/s10741-010-9212-4.
- Background: PubMed 21884950Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.
- Background: PubMed 21791536Bogaard MD, Houthuizen P, Bracke FA, Doevendans PA, Prinzen FW, Meine M, van Gelder BM. Baseline left ventricular dP/dtmax rather than the acute improvement in dP/dtmax predicts clinical outcome in patients with cardiac resynchronization therapy. Eur J Heart Fail. 2011 Oct;13(10):1126-32. doi: 10.1093/eurjhf/hfr094. Epub 2011 Jul 26.
- Background: PubMed 15851221Butter C, Stellbrink C, Belalcazar A, Villalta D, Schlegl M, Sinha A, Cuesta F, Reister C. Cardiac resynchronization therapy optimization by finger plethysmography. Heart Rhythm. 2004 Nov;1(5):568-75. doi: 10.1016/j.hrthm.2004.07.002.
- Center for Cardiological InnovationLink provided by the sponsor.
- Oslo University HospitalLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy device implantation in people with Heart Failure and Resynchronization Therapy, run by Oslo University Hospital at 1 site in Norway.
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 13 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 31 Mar 2016. 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 Norway. 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?
dP\dt max response to different ventricular lead pacing sites (time frame: 6 months). 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 NCT01996397, which also lists 20 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 31 Mar 2016.