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CT Guided WiSE-CRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495505
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Heart Failure Device: WiSE-CRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 20 patients will be recruited into this feasibility study with a 6 month follow-up. There will be no blinding nor randomisation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Optimisation and Guidance for Wireless Endocardial Cardiac Resynchronisation Therapy: The CT Guided Trial
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: WiSE-CRT eligible
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
Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.
Other Names:
  • Cardiac Resynchronisation Therapy
  • Wireless Endocardial Pacing
  • WICS device




Primary Outcome Measures :
  1. Change in acute haemodynamic response (dp/dt) during the procedure [ Time Frame: Baseline and during procedure ]

Secondary Outcome Measures :
  1. Change in Minnesota Living with Heart Failure Questionnaire Score [ Time Frame: Baseline and 6 months ]
    This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.

  2. Evidence of reverse remodelling (≥15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation [ Time Frame: Baseline and 6 months ]
  3. Change in 6 minute walk test [ Time Frame: Baseline and 6 months ]
  4. Change in cardio-pulmonary exercise test score [ Time Frame: Baseline and 6 months ]
    This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495505


Contacts
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Contact: Steven Niederer, DPhil 02071889257 steven.niederer@kcl.ac.uk
Contact: Baldeep S Sidhu, BM 02071889257 baldeep.sidhu@nhs.net

Locations
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United Kingdom
Guys and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Christopher A Rinaldi, FRCP    02071888188 ext 89257      
Contact: Baldeep S Sidhu, BM    02071888188 ext 89257      
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Steven Niederer, DPhil King's College London
Publications:

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03495505    
Other Study ID Numbers: 239322
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
WiSE-CRT
Endocardial Pacing Optimisation
Cardiac Resynchronisation Therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases