Status:
COMPLETED
A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Heart Research UK
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the symptoms of selected patients with heart failure, and to reduce hospital admission and death rates in these...
Detailed Description
CRT as a treatment for heart failure in selected patients has been shown to decrease both hospitalizations and mortality as well as improving symptoms and quality of life, and is hence supported by gu...
Eligibility Criteria
Inclusion
- Participants with standard indications for CRT AND
- Unable to position a LV lead via the standard coronary sinus route OR
- Non-responder to conventional CRT
Exclusion
- Patients in whom, in the opinion of the investigators, an alternative route for LV lead placement would be safer or more effective for the patient
- Contraindications to oral anticoagulation or inability to safely take oral anticoagulation.
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Participant who is terminally ill
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01818765
Start Date
May 1 2013
End Date
March 1 2018
Last Update
March 3 2020
Active Locations (1)
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1
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7AT