Study to Evaluate System Safety and Clinical Performance of the Protecta Implantable Cardioverter Defibrillator (ICD) Plus Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Clinical Study to assess the Capacity of the Protecta Features to Reduce Inappropriate Shocks (Phase II, PainFree SST). - PainFree SST Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000657

Enrollment

2000

Registered

2010-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Tachyarrhythmias Heart Failure Ventricular Dysfunction

Interventions

Intervention1: VF NID 18/24: Active Comparator: Device: Protecta Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Secondary prevention subjects

Eligibility

Inclusion criteria

Inclusion criteria: Patients meeting one of the following criteria can be included in Phase II of the study: Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant

Exclusion criteria

Exclusion criteria: Patients with a mechanical tricuspid heart valve Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc) Patients anticipated not being able to complete the study Patients unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Percentage of subjects who are inappropriate shock freeTimepoint: Implant to one year post-implant	—

Secondary

Measure	Time frame
Percentage of secondary prevention subjects who are syncopal event freeTimepoint: Implant to one year post-implant	—

Countries

Canada, Colombia, Czech Republic, Denmark, Germany, India, Israel, Italy, Japan, Netherlands, United Kingdom, United States of America

Contacts

Public ContactRajesh Radhakrishnan

rajesh.radhakrishnan@medtronic.com022-33074700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026