LV Endocardial Cardiac Resynchronisation Therapy

Heart Failure Clinical Trial

— ENDO-CRT  

Official title:

A Randomised Double-blinded Cross Over Study to Evaluate the Improvement of Left Ventricular Systolic Failure Using Targeted Left Ventricular Endocardial Lead Placement in Cardiac Resynchronisation Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02174289
• Other study ID #: 2013PS003H
• Secondary ID: ISROTH20092
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2014
• Last updated: June 26, 2014
• Start date: April 2014

Study information

• Verified date: June 2014
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Charles Butcher, MBBS MRCP
• Email: c.butcher[@]rbht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. Lack of clinical response may be the result of imperfect left ventricular lead placement in the veins around the heart with conventional techniques. Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred heart muscle or may not be at the site of latest electrical depolarisation. In a further 10% of patients, conventional left ventricular lead placement is not possible for other technical reasons.

Left ventricular endocardial lead placement may overcome the limitations and allow placement to be guided by echocardiography, electrical mapping and the pattern of heart muscle scarring.

We aim to investigate if targeted left ventricular endocardial lead placement improves exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency and biochemical markers of heart strain. Each parameter will be assessed independently and as part of a composite cardiac performance score.

Patients with heart failure will be enrolled who require an endocardial left ventricular lead on clinical grounds as either conventional left ventricular lead implantation has technically failed or they have clinically non-responded to CRT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• NYHA class II-IV

• LVEF =35%

• QRS =120 milliseconds

• Optimal tolerated medical therapy

• Either unable to position an LV lead via the standard coronary sinus on CRT implantation

• OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation

• Informed consent

Exclusion Criteria:

• Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders

• Previous atrial septal defect device closure.

• Chronic renal dialysis and End stage liver disease

• History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months

• Presence of correctable valvular disease (aortic/mitral)

• Mitral valve prosthesis.

• Contra indication to vitamin K antagonist

• Unresolved intra-cardiac thrombus

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Targeted left ventricular endocardial lead placement
The left ventricular endocardial lead will be passed through the intra-atrial septum

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Cleland 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. Epub 2005 Mar 7. — View Citation

Gras D, Böcker D, Lunati M, Wellens HJ, Calvert M, Freemantle N, Gervais R, Kappenberger L, Tavazzi L, Erdmann E, Cleland JG, Daubert JC; CARE-HF Study Steering Committee and Investigators. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace. 2007 Jul;9(7):516-22. Epub 2007 May 31. — View Citation

Jaïs P, Douard H, Shah DC, Barold S, Barat JL, Clémenty J. Endocardial biventricular pacing. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 1):2128-31. — View Citation

Jaïs P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haïssaguerre M, Clémenty J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1744-7. — View Citation

Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7. — View Citation

McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. Erratum in: Eur Heart J. 2013 Jan;34(2):158. — View Citation

Nuta B, Lines I, MacIntyre I, Haywood GA. Biventricular ICD implant using endocardial LV lead placement from the left subclavian vein approach and transseptal puncture via the transfemoral route. Europace. 2007 Nov;9(11):1038-40. Epub 2007 Aug 17. — View Citation

Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8. — View Citation

Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014. — View Citation

van Gelder BM, Scheffer MG, Meijer A, Bracke FA. Transseptal endocardial left ventricular pacing: an alternative technique for coronary sinus lead placement in cardiac resynchronization therapy. Heart Rhythm. 2007 Apr;4(4):454-60. Epub 2006 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Freedom from adverse events	Acute: Tamponade, effusion, systemic thromboembolism; acute lead displacement and arrhythmia; Chronic: systemic thromboembolism; lead displacement, disfunction or fracture; device related systemic infection; bleeding; arrhythmia	1 year	Yes
Other	Medium term clinical outcomes	Assess medium term response to treatment with regards to symptoms, exercise tolerance, echocardiographic and biochemical parameters (as specified above), particularly systemic thrombosis.	6 months	Yes
Other	Targeting success	Success at targeting the site which produces the greatest haemodynamic response using echocardiogaphic speckle tracking, endocardial electrical mapping and myocardial perfusion scintigraphy.	Intra operative	No
Primary	Cardiopulmonary Exercise Test	Improvement in peak oxygen consumption	3 months	No
Secondary	New NYHA Class	Change in New York Heart Association functional Class	3 months	No
Secondary	6 minute walk	Change in 6 minute hall walk test distance	3 months	No
Secondary	Quality of life	Minnesota Living with heart failure questionnaire score	3 months	No
Secondary	Echocardiography	Change in size and function of the heart	3 months	No
Secondary	Digital photoplethysmography	Cardiac output	3 months	No
Secondary	Biochemical response	Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels.	3 months	No
Secondary	Composite cardiac assessment score	Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters.	3 months	No