Attain Model 4196 Left Ventricular (LV) Lead
24. september 2009 opdateret af: Medtronic Cardiac Rhythm and Heart Failure
Heart failure is a progressive disease that decreases the pumping action of the heart.
This may cause a backup of fluid in the heart and may result in heart beat changes.
When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat.
In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed.
CRT is similar to a pacemaker.
It is placed (implanted) under the skin of the upper chest.
CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart.
The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
190
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada
-
Edmonton, Alberta, Canada
-
-
Ontario
-
Toronto, Ontario, Canada
-
-
Quebec
-
Montreal, Quebec, Canada
-
Sainte-Foy, Quebec, Canada
-
-
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater
-
-
California
-
Long Beach, California, Forenede Stater
-
Palo Alto, California, Forenede Stater
-
-
Iowa
-
Davenport, Iowa, Forenede Stater
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater
-
-
Michigan
-
Detroit, Michigan, Forenede Stater
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater
-
-
North Carolina
-
Raleigh, North Carolina, Forenede Stater
-
-
Ohio
-
Mayfield Heights, Ohio, Forenede Stater
-
-
Pennsylvania
-
Wynnewood, Pennsylvania, Forenede Stater
-
-
South Carolina
-
Spartanburg, South Carolina, Forenede Stater
-
-
Tennessee
-
Kingsport, Tennessee, Forenede Stater
-
Memphis, Tennessee, Forenede Stater
-
-
Texas
-
Dallas, Texas, Forenede Stater
-
Fort Worth, Texas, Forenede Stater
-
-
Vermont
-
Burlington, Vermont, Forenede Stater
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
- Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
- Subject has moderate to severe heart failure despite medications
Exclusion Criteria:
- Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
- Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
- Subjects that have had certain surgeries on their heart within the past three months
- Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 4196 Lead
Non-randomized study.
|
implantation og opfølgning af studieapparat
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety (Subjects Without a Model 4196 Lead Related Complication)
Tidsramme: One Month
|
A subject who was free of a Model 4196 lead related complication by one month visit.
|
One Month
|
|
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
Tidsramme: One Month
|
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
|
One Month
|
|
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
Tidsramme: Three Months
|
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
|
Three Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjects Successfully Implanted With Model 4196 Lead
Tidsramme: Implant
|
A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.
|
Implant
|
|
Subjects Successfully Implanted After Cannulation
Tidsramme: Implant
|
A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.
|
Implant
|
|
All Left Ventricular Leads
Tidsramme: Implant
|
All left ventricular leads successfully implanted
|
Implant
|
|
All Medtronic Left Ventricular Leads (Attain Family)
Tidsramme: Implant
|
All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
|
Implant
|
|
Cannulation Time
Tidsramme: Implant
|
Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
|
Implant
|
|
Fluoroscopy Time
Tidsramme: Implant
|
Fluoroscopy time was defined as the total time the fluoroscope was imaging.
|
Implant
|
|
Model 4196 Lead Placement Time
Tidsramme: Implant
|
Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.
|
Implant
|
|
Total Implant Time
Tidsramme: Implant
|
Total implant time was defined as time from initial incision to final closure.
|
Implant
|
|
Assessment of Lead Handling Characteristics
Tidsramme: Implant
|
Lead handling characteristics assessed as "acceptable" by physicians
|
Implant
|
|
Electrical Performance - Tip Electrode: Sensing
Tidsramme: 12-month
|
Model 4196 lead tip electrode R-wave amplitude
|
12-month
|
|
Electrical Performance - Tip Electrode: LV Voltage Threshold
Tidsramme: 12-month
|
Model 4196 lead tip electrode LV voltage threshold
|
12-month
|
|
Electrical Performance -Tip Electrode: Pacing Impedance
Tidsramme: 12-month
|
Model 4196 lead tip electrode pacing impedance
|
12-month
|
|
Electrical Performance -Ring Electrode: Sensing
Tidsramme: Implant
|
Model 4196 lead ring electrode R-wave amplitude
|
Implant
|
|
Electrical Performance - Ring Electrode: LV Voltage Threshold
Tidsramme: 12-month
|
Model 4196 lead ring electrode LV voltage threshold
|
12-month
|
|
Electrical Performance -Ring Electrode: Pacing Impedance
Tidsramme: 12-Month
|
Model 4196 lead ring electrode pacing impedance
|
12-Month
|
|
Summarize All Adverse Events
Tidsramme: Up to 18 months
|
All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
|
Up to 18 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Brian Ramza, MD, PHD, St. Luke's Mid America Heart Institute, Kansas City MO
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2007
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. december 2008
Datoer for studieregistrering
Først indsendt
28. december 2005
Først indsendt, der opfyldte QC-kriterier
30. december 2005
Først opslået (Skøn)
2. januar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. september 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2009
Sidst verificeret
1. september 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 241 (Registry Identifier: University Clinical Research Ethics Committee (Turkey))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .