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

NCT ID: NCT03632057

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 779 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2025-04-18

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.

Detailed Description

The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.

Conditions

Ventricular Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed Tilt (65%)

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

Group Type: ACTIVE_COMPARATOR

Fixed Tilt (65%)

Intervention Type: DEVICE

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

Fixed Pulse Width

This is the Study group.

Group Type: ACTIVE_COMPARATOR

Fixed Pulse Width

Intervention Type: DEVICE

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

Interventions

Fixed Tilt (65%)

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

Intervention Type: DEVICE

Fixed Pulse Width

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • 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)

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

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignacio Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Javier Alzueta, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Puerta de Hierro

Madrid, , Spain

Countries

Spain

Other Identifiers

CRD_914

Identifier Type: -

Identifier Source: org_study_id