CT Guided WiSE-CRT
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|ClinicalTrials.gov Identifier: NCT03495505|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: WiSE-CRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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)|
|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|
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.
Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.
- Change in acute haemodynamic response (dp/dt) during the procedure [ Time Frame: Baseline and during procedure ]
- 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.
- 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 ]
- Change in 6 minute walk test [ Time Frame: Baseline and 6 months ]
- 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.
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
|Contact: Steven Niederer, DPhilfirstname.lastname@example.org|
|Contact: Baldeep S Sidhu, BMemail@example.com|
|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|
|Principal Investigator:||Steven Niederer, DPhil||King's College London|