Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment

NCT01426321 | Completed

• 1 other identifier: CRTCLIN01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment. New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.

Conditions

Heart Failure

Keywords

Cardiac resynchronization therapy; Echocardiography; Cardiac computed tomography

Outcome Measures

Primary Outcomes (1)

• Positive response to CRT treatment

  The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician). Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume ≥ 15% by echocardiography ("volume responder") and / or improvement ≥ 1 NYHA class and ≥10% improvement in 6 minute hall walk test ("clinical responder").

  6 months

Secondary Outcomes (13)

• Response to CRT (on-treatment analysis)

  6 months

• Heart failure morbidity

  6 months 2 years and 5 years

• Morbidity and mortality

  6 months 2 years and 5 years

• Mortality

  6 months, 2 years and 5 years

• Left ventricular dyssynchrony

  6 months

Study Arms (2)

Imaging guided LV lead positioning

ACTIVE COMPARATOR

Other: Imaging guided LV lead positioning

Standard LV lead positioning

NO INTERVENTION

The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available.

Interventions

Imaging guided LV lead positioning OTHER

LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images.

Imaging guided LV lead positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
• Wide QRS ≥ 120 milliseconds on standard ECG.
• LV systolic dysfunction (EF ≤ 35%).
• Written informed consent.
• Accepted for CRT-P or CRT-D treatment

You may not qualify if:

• Life expectancy \< 12 months.
• Recent myocardial infarction (\< 3 months).
• Significant valve disease
• Chronic atrial fibrillation
• Pregnancy
• Severely impaired renal function (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
• Unable to give written informed consent.

Sponsors & Collaborators

• Region Skane: lead
• Crafoord Foundation: collaborator

Study Sites (1)

Skane University Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

• Borgquist R, Carlsson M, Markstad H, Werther-Evaldsson A, Ostenfeld E, Roijer A, Bakos Z. Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study. JACC Clin Electrophysiol. 2020 Oct;6(10):1300-1309. doi: 10.1016/j.jacep.2020.05.011. Epub 2020 Aug 12.

  PMID: 33092758 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rasmus Borgquist, MD PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

SE (1)