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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00982397
First received: September 22, 2009
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated. Phase II of the study will begin when the Medtronic Protecta devices are market released in each participating geography. Subjects enrolled into Phase I of the study will continue follow up in Phase II.


Condition Intervention
Tachyarrhythmias
Heart Failure
Ventricular Dysfunction
Device: Protecta Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The PainFree SST Clinical Study. Clinical Study to Evaluate System Safety and Clinical Performance of the Protecta ICD + CRT-D (Phase I, Protecta Clinical Study) and to Assess the Capacity of the Protecta Features to Reduce Inappropriate Shocks (Phase II, PainFree SST).

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Percentage of subjects with unanticipated severe adverse device effects [ Time Frame: Implant to one month post-implant ] [ Designated as safety issue: No ]
    Primary objective of Phase I

  • Percentage of subjects where the ventricular fibrillation (VF) detection time with Protecta features on is no more than 2 seconds longer than the VF detection time with Protecta features off [ Time Frame: At implant ] [ Designated as safety issue: No ]
    Primary objective of Phase I

  • Percentage of subjects who are inappropriate shock free [ Time Frame: Implant to one year post-implant ] [ Designated as safety issue: No ]
    Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device.


Secondary Outcome Measures:
  • Percentage of secondary prevention subjects who are syncopal event free [ Time Frame: Implant to one year post-implant ] [ Designated as safety issue: No ]

Enrollment: 2791
Study Start Date: September 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VF NID 18/24
VF NID (ventricular fibrillation number of intervals to detect) will be programmed to 18/24
Device: Protecta Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Secondary prevention subjects will have their device programmed to VF NID 18/24. VF NID (ventricular fibrillation number of intervals to detect) is a programmed parameter and indicates if 18 of the last 24 beat to beat intervals are shorter than the VF detection interval the device will detect ventricular fibrillation and initiate therapy to treat the rhythm.
Active Comparator: VF NID 30/40
VF NID (ventricular fibrillation number of intervals to detect) will be programmed to 30/40
Device: Protecta Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Secondary prevention subjects will have their device programmed to VF NID 30/40. VF NID (ventricular fibrillation number of intervals to detect) is a programmed parameter and indicates if 30 of the last 40 beat to beat intervals are shorter than the VF detection interval the device will detect ventricular fibrillation and initiate therapy to treat the rhythm.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting one of the following criteria can be included in Phase I of the study:

    • Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
    • Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
  • 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982397

  Show 124 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: A. Meijer, Dr. Eindhoven, The Netherlands
Principal Investigator: A. Auricchio, Prof. Lugano, Switzerland
Principal Investigator: T. Kurita, Dr. Higashi-Osaka, Japan
Principal Investigator: E.J. Schloss, Dr. Cincinnati Ohio, USA
Principal Investigator: L. Sterns, Dr. Victoria, British Columbia, Canada
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00982397     History of Changes
Other Study ID Numbers: PainFree SST
Study First Received: September 22, 2009
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Austria: Federal bureau for security in publich health AGES PharmMed
Czech Republic: Ministery of Health
Denmark: Danish Medicines Agency
Germany: Competent Authority
Israel: Ministry of Health
Italy: Ministero della Salute Direzione Generale dei Farmaci e Dispositivi Medici
The Netherlands: Federal Ministry of Social Affairs,Public Health and Environment Service Medical Aids
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
South Africa: Department of Health
Spain: Spanish Agency of Medicines and Sanitary Products
Sweden: Medical Products Agency
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Kingdom of Saudi Arabia: Not Applicable
United Arab Emirates: Not Applicable
India: Institutional Review Board
Canada: Ethics Review Committee
China: Ethics Committee
Japan: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Tachycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014