Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)

NCT ID: NCT03412240

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2020-03-10

Brief Summary

Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.

Detailed Description

Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.

Conditions

Arrythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anti tachycardia pacing

Group Type: EXPERIMENTAL

Induced pacing of the heart

Intervention Type: PROCEDURE

Once the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate.

Interventions

Induced pacing of the heart

Once the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change

Exclusion Criteria

• Contraindications to defibrillator testing e.g. severe untreatable coronary disease Intracardiac thrombus Interruption of anticoagulation Participants undergoing box change, device upgrade or revision Inability or unwillingness to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Muzahir Tayebjee, MBChB (Hons) MD MRCP

Role: CONTACT

muzahir.tayebjee@nhs.net

+441133926619

Facility Contacts

Muzahir Tayebjee, MBChB (Hons) MD MRCP

Role: primary

Other Identifiers

CD16/90568

Identifier Type: -

Identifier Source: org_study_id