Heart Failure Clinical Trial
Official title:
Image Optimisation and Guidance for Wireless Endocardial Cardiac Resynchronisation Therapy: The CT Guided Trial
NCT number | NCT03495505 |
Other study ID # | 239322 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 31, 2018 |
Est. completion date | May 5, 2021 |
Verified date | March 2022 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This feasibility study will use CT scanning to identify the optimal location for placement of the WiSE-CRT system.
Status | Completed |
Enrollment | 11 |
Est. completion date | May 5, 2021 |
Est. primary completion date | May 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guys and St Thomas' NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | National Institute for Health Research, United Kingdom |
United Kingdom,
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. Review. — View Citation
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-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. Erratum in: Eur Heart J. 2016 Dec 30;:. — View Citation
Reddy VY, Miller MA, Neuzil P, Søgaard 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in acute haemodynamic response (dp/dt) during the procedure | Baseline and during procedure | ||
Secondary | Change in Minnesota Living with Heart Failure Questionnaire Score | This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome. | Baseline and 6 months | |
Secondary | Evidence of reverse remodelling (=15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation | Baseline and 6 months | ||
Secondary | Change in 6 minute walk test | Baseline and 6 months | ||
Secondary | Change in cardio-pulmonary exercise test score | This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome. | Baseline and 6 months |
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