Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

NCT03632057 | Completed

• 1 other identifier: CRD_914
• Study Type: interventional
• Target: 779
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.

Conditions

Ventricular Arrythmia

Outcome Measures

Primary Outcomes (1)

• Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm

  Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).

  5 years

Study Arms (2)

Fixed Tilt (65%)

ACTIVE COMPARATOR

This is the control group, so device programming for shock energy is the default setting

Device: Fixed Tilt (65%)

Fixed Pulse Width

ACTIVE COMPARATOR

This is the Study group.

Device: Fixed Pulse Width

Interventions

Fixed Tilt (65%) DEVICE

This is the standard group, so device programming for shock energy is the default setting

Fixed Tilt (65%)

Fixed Pulse Width DEVICE

The device has to be programmed with fixed pulse width for each phase of the biphasic waveform

Fixed Pulse Width

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
• Subjects who are willing to be registered on the Merlin.net remote follow-up program
• Subject ≥18 years
• Subjects with life expectancy of at least 1 year
• Subjects who agree to comply with the follow-up program included in this protocol

You may not qualify if:

• Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
• Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
• Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
• Functional NYHA Class IV
• Subjects who are participating in another ICD or CRT-D study
• Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
• Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Study Officials

• Ignacio Fernandez, MD

  PRINCIPAL INVESTIGATOR

• Javier Alzueta, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 15, 2018
• Study Start: June 6, 2018
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)