CT Guided WiSE-CRT

NCT03495505 | Completed

• 1 other identifier: 239322
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will use CT scanning to identify the optimal location for placement of the WiSE-CRT system.

Conditions

Heart Failure

Keywords

WiSE-CRT; Endocardial Pacing Optimisation; Cardiac Resynchronisation Therapy

Outcome Measures

Primary Outcomes (1)

• Change in acute haemodynamic response (dp/dt) during the procedure

  Baseline and during procedure

Secondary Outcomes (4)

• Change in Minnesota Living with Heart Failure Questionnaire Score

  Baseline and 6 months

• Evidence of reverse remodelling (≥15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation

  Baseline and 6 months

• Change in 6 minute walk test

  Baseline and 6 months

• Change in cardio-pulmonary exercise test score

  Baseline and 6 months

Study Arms (1)

WiSE-CRT eligible

EXPERIMENTAL

Patients need to meet all the inclusion and none of the exclusion criteria in order to be eligible for the study. All these patients will receive the WiSE-CRT implant.

Device: WiSE-CRT

Interventions

WiSE-CRT DEVICE

Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.

Also known as: Cardiac Resynchronisation Therapy, Wireless Endocardial Pacing, WICS device

WiSE-CRT eligible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
• Patients with pre-existing permanent pacing systems in situ.
• Left ventricular systolic impairment with ejection fraction of \<45%
• Clinical symptoms of heart failure despite optimal medical therapy (NYHA II- IV)
• QRS duration \>120ms on surface ECG

You may not qualify if:

• Creatinine clearance \<30mls/minute (GFR)
• Severe allergy to contrast medium or severe asthma/ COPD
• Life expectancy \<1 year
• Significant aortic valve disease or prosthesis
• Significant mitral regurgitation
• Significant peripheral vascular disease
• Contraindication to anticoagulation therapy
• Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography
• Left atrial or ventricular thrombus

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (4)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Reddy VY, Miller MA, Neuzil P, Sogaard P, Butter C, Seifert M, Delnoy PP, van Erven L, Schalji M, Boersma LVA, Riahi S. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129. doi: 10.1016/j.jacc.2017.02.059.

  PMID: 28449772 BACKGROUND

• Ypenburg C, van Bommel RJ, Delgado V, Mollema SA, Bleeker GB, Boersma E, Schalij MJ, Bax JJ. Optimal left ventricular lead position predicts reverse remodeling and survival after cardiac resynchronization therapy. J Am Coll Cardiol. 2008 Oct 21;52(17):1402-9. doi: 10.1016/j.jacc.2008.06.046.

  PMID: 18940531 BACKGROUND

• Miller MA, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers: Back to the Future. J Am Coll Cardiol. 2015 Sep 8;66(10):1179-89. doi: 10.1016/j.jacc.2015.06.1081.

  PMID: 26337997 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Steven Niederer, DPhil

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 patients will be recruited into this feasibility study with a 6 month follow-up. There will be no blinding nor randomisation.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 12, 2018
• Study Start: August 31, 2018
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)