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Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device (CLEPSYDRA)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paradym CRT 8770
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring HF, diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
  • Severe HF (NYHA Class III or IV) at the time of enrollment
  • At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
  • Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
  • Scheduled for implant of a PARADYM 8770
  • Signed and dated informed consent

Exclusion Criteria:

  • Any contraindication for standard cardiac pacing
  • Any contraindication for ICD therapy
  • Abdominal implantation side
  • Hypertrophic or obstructive cardiomyopathy
  • Acute myocarditis
  • Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
  • Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
  • Correctable valvular disease that is the primary cause of heart failure
  • Mechanical tricuspid valve
  • Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
  • Heart transplant recipient
  • Renal insufficiency requiring dialysis
  • Already included in another clinical study
  • Life expectancy less than 12 months
  • Inability to understand the purpose of the study or refusal to cooperate
  • Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Unavailability for scheduled follow-up at the implanting center
  • Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
  • Under guardianship
  • Age of less than 18 years
  • Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

Sites / Locations

  • Dr. Haines
  • Drs. Lewis, Garg
  • Drs. Jagmeet Singh, Kevin, Hiest
  • Drs. John Fisher, Jay Gross
  • Dr. Gold
  • Dr. Champagne, Dr. Philippon
  • Drs. Thibualt, Guerra
  • Dr. Dupuis
  • Dr. Defaye
  • Dr. Bru
  • Pr. Kacet
  • Dr. Pisapia
  • Pr. Davy
  • Dr. Burban
  • Dr Abbey
  • Dr. Jauvert
  • Dr. Ritter
  • Pr. Mabo
  • Pr. Anselme
  • Pr. Da Costa
  • Dr. Delay
  • Pr. Sadoul
  • Dr. Sperzel
  • Dr. Vogt
  • Dr. Fleck - Dr. Goetze
  • Dr. Schlegl
  • Dr. Butter
  • Pr. Brachmann
  • Dr. Klein - Dr. Oswald
  • Pr. Bauer
  • Pr. Mewis - Pr. Fröhlig
  • Dr. Wieckhorst
  • Dr. Bonnemeier
  • Pr. Weiss
  • Dr. Kolb
  • Pr. Eckhardt
  • Dr. Leonardo Calo
  • Dr Mantovan
  • Dr. Delnoy
  • Dr. Martinez
  • Dr. Brugada
  • Dr. Peinado
  • Dr. Beiras
  • Dr Auricchio
  • Dr. Leyva
  • Dr Fluck - Dr. Beeton
  • Dr. NG
  • Dr. Murgatroyd
  • Dr. Bowes
  • Dr. Morgan

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

PhD

Arm Description

Outcomes

Primary Outcome Measures

Number of HF related events

Secondary Outcome Measures

Co morbidities

Full Information

First Posted
June 17, 2014
Last Updated
June 17, 2014
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT02167789
Brief Title
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
Acronym
CLEPSYDRA
Official Title
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

5. Study Description

Brief Summary
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
Detailed Description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
HF, diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PhD
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Paradym CRT 8770
Primary Outcome Measure Information:
Title
Number of HF related events
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Co morbidities
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy Severe HF (NYHA Class III or IV) at the time of enrollment At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure Scheduled for implant of a PARADYM 8770 Signed and dated informed consent Exclusion Criteria: Any contraindication for standard cardiac pacing Any contraindication for ICD therapy Abdominal implantation side Hypertrophic or obstructive cardiomyopathy Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Recent (within the last month) or planned cardiac revascularization or coronary angioplasty Correctable valvular disease that is the primary cause of heart failure Mechanical tricuspid valve Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week Heart transplant recipient Renal insufficiency requiring dialysis Already included in another clinical study Life expectancy less than 12 months Inability to understand the purpose of the study or refusal to cooperate Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization Unavailability for scheduled follow-up at the implanting center Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP) Under guardianship Age of less than 18 years Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Facility Information:
Facility Name
Dr. Haines
City
Kaplan, Phoenix,
State/Province
Arizona
Country
United States
Facility Name
Drs. Lewis, Garg
City
Siegel, Phoenix,
State/Province
Arizona
Country
United States
Facility Name
Drs. Jagmeet Singh, Kevin, Hiest
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Drs. John Fisher, Jay Gross
City
Montefiore, Bronx NY
State/Province
New York
Country
United States
Facility Name
Dr. Gold
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Dr. Champagne, Dr. Philippon
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Drs. Thibualt, Guerra
City
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Dr. Dupuis
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Dr. Defaye
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Dr. Bru
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Pr. Kacet
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Dr. Pisapia
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Pr. Davy
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Dr. Burban
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Dr Abbey
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Dr. Jauvert
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
Dr. Ritter
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Pr. Mabo
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Pr. Anselme
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Pr. Da Costa
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Dr. Delay
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Pr. Sadoul
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Dr. Sperzel
City
Bad Nauheim
ZIP/Postal Code
D-61231
Country
Germany
Facility Name
Dr. Vogt
City
Bad Oeynhausen
ZIP/Postal Code
D-32545
Country
Germany
Facility Name
Dr. Fleck - Dr. Goetze
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Dr. Schlegl
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Dr. Butter
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Pr. Brachmann
City
Coburg
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Dr. Klein - Dr. Oswald
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Pr. Bauer
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Pr. Mewis - Pr. Fröhlig
City
Homburg
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Dr. Wieckhorst
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Dr. Bonnemeier
City
Lübeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
Pr. Weiss
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Dr. Kolb
City
Munchen
ZIP/Postal Code
80636
Country
Germany
Facility Name
Pr. Eckhardt
City
Münster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Dr. Leonardo Calo
City
Roma
ZIP/Postal Code
00169
Country
Italy
Facility Name
Dr Mantovan
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Dr. Delnoy
City
Zwolle
ZIP/Postal Code
10500
Country
Netherlands
Facility Name
Dr. Martinez
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Dr. Brugada
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Dr. Peinado
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Dr. Beiras
City
Vigo
ZIP/Postal Code
3204
Country
Spain
Facility Name
Dr Auricchio
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Dr. Leyva
City
Birmingham
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Dr Fluck - Dr. Beeton
City
Chertsey
ZIP/Postal Code
KT160PZ
Country
United Kingdom
Facility Name
Dr. NG
City
Leicester
ZIP/Postal Code
LE3 9PQ
Country
United Kingdom
Facility Name
Dr. Murgatroyd
City
London
ZIP/Postal Code
WC2R 2LS
Country
United Kingdom
Facility Name
Dr. Bowes
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Dr. Morgan
City
Southampton
ZIP/Postal Code
SO16 9YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

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