Contak cd clinical study

CLINICAL SUMMARY CONTAK CD - Boston Scientific

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CLINICAL STUDY - CONTAK CD ADVERSE EVENTS 4 US MnO2 Draft - 1/14/11 Deaths A total of 109 deaths occurred during the study. These deaths occurred during the study periods as shown in Table 2 along with the cause of death as adjudicated by an independent events committee.

CLINICAL SUMMARY CONTAK CD - Boston Scientific

CLINICAL SUMMARY CONTAK RENEWAL - Boston Scientific

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CLINICAL STUDY - CONTAK RENEWAL SUMMARY Guidant conducted the CONTAK RENEWAL Study, which demonstrated the ... upon which the ICD function of CONTAK CD and CONTAK RENEWAL are built, Guidant's ICDs typically have a VF detection time of approximately two seconds. The VF detection time of 2.4 ± 0.5 seconds in

CLINICAL SUMMARY CONTAK RENEWAL - Boston Scientific

Cardiac resynchronization therapy in patients with right ...

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The Contak CD study was a prospective randomized, controlled, multicenter, double-blind study that enrolled a total of 581 patients. 4 Entry criteria for participation included patients with NYHA class II to IV, LVEF ≤35%, QRS duration ≥120 ms, and conventional indications for implantable cardioverter-defibrillator placement. Patients in ...

Cardiac resynchronization therapy in patients with right ...

contak ® cd - Boston Scientific - slidegur.com

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contak ® cd - Boston Scientific + Report

contak ® cd - Boston Scientific - slidegur.com

Cardiac resynchronization therapy in patients with right ...

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The Contak CD study was a prospective randomized, controlled, multicenter, double-blind study that enrolled a total of 581 patients.4 Entry criteria for participation in-cluded patients with NYHA class II to IV, LVEF 35%, QRS duration 120 ms, and conventional indications for implantable cardioverter-defibrillator placement. Patients in

Cardiac resynchronization therapy in patients with right ...

SUMMARY OF SAFETY AND EFFECTIVENESS 1 GENERAL …

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Summary of Safety and Effectiveness . 5 • Prolonged exposure to fluoroscopic radiation •Renal failure from contrast media used to visualize coronary veins . 10 SUMMARY OF PRE-CLINICAL STUDIES . Guidant's commercially available CONTAK CD system was implanted for the CRT­ D device arm of the COMPANION study. The CONTAK CD system was previously

SUMMARY OF SAFETY AND EFFECTIVENESS 1 GENERAL …

Clinical trials update: Highlights of the Scientific ...

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This is a summary of presentations made at Scientific Sessions of Heart Failure 2001, a meeting of the Working Group on Heart Failure of the European Society of Cardiology. Clinical studies of particular interest to people caring for patients with heart failure include CONTAK-CD, CHRISTMAS and further updates on OPTIME-CHF.

Clinical trials update: Highlights of the Scientific ...

Cardiac resynchronization therapy in patients with right ...

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We pooled data from all patients with RBBB from both the MIRACLE and CONTAK CD trials. A new database was created by entering all baseline, clinical, and outcome variables into an Excel spreadsheet. Preimplant 12-lead surface ECGs were analyzed to verify the presence of RBBB.

Cardiac resynchronization therapy in patients with right ...

Performance of a New Steroid-Eluting Coronary Sinus Lead ...

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The Ventak CHF/CONTAK CD Biventricular Pacing Study is a prospective randomized trial to examine the safety and efficacy of biventricular (BV) pacing in patients with standard indications for an ICD, symptomatic heart failure, a LVEF ≤ 0.35, and a QRS ≥ 120 ms.

Performance of a New Steroid-Eluting Coronary Sinus Lead ...

Boston Scientific - Guidant Press Releases

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Indianapolis, IN - Guidant Corporation (NYSE and PSX: GDT), a worldwide leader in cardiac rhythm management systems, today announced the start of a clinical study to …

Boston Scientific - Guidant Press Releases

Boston Scientific - Guidant Press Releases

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COMPANION Study Stopped Due to Significant Reduction in Combined All-Cause Mortality and All-Cause Hospitalization Cardiac Resynchronization Therapy …

Boston Scientific - Guidant Press Releases

Clinical Trials of Cardiac Resynchronization Therapy ...

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Figure 12-3 Study design of three U.S. trials. CONTAK CD Biventricular Pacing Study (CONTAK CD), Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD), and Multicenter InSync Randomized Clinical Evaluation (MIRACLE); 6MW, 6-mile walk distance; CPX, cardiopulmonary exercise test; CRT, cardiac resynchronization therapy.

Clinical Trials of Cardiac Resynchronization Therapy ...

Septal to Posterior Wall Motion Delay Fails to Predict ...

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12/20/2005 · Septal to Posterior Wall Motion Delay Fails to Predict Reverse Remodeling or Clinical Improvement in Patients Undergoing Cardiac Resynchronization Therapy Emily Rose, Gregory M. Marcus, Esperanza M. Viloria, Jill Schafer, Teresa De Marco, Leslie A. Saxon, Elyse Foster, for the VENTAK CHF/CONTAK-CD Biventricular Pacing Study Investigators This study was designed to test …

Septal to Posterior Wall Motion Delay Fails to Predict ...

Cardiac resynchronisation may reduce all-cause mortality ...

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All patients enrolled in the CONTAK CD trial , , similar to the InSync ICD, had a clinical indication for ICD. All patients were implanted with combined devices and randomised to have the biventricular pacing element switched on or off. Initially, a 3-month crossover design was used but was later changed to a 6-month parallel study.

Cardiac resynchronisation may reduce all-cause mortality ...

Bad Oeynhausen Experience | European Heart Journal ...

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8/1/2004 · The CONTAK CD Investigators: Cardiac resynchronization therapy in heart failure (CONTAK CD) clinical study. Presented at the meeting of the North American Society of Pacing Electrophysiologists, Boston, MA; 2001

Bad Oeynhausen Experience | European Heart Journal ...

Cardiac resynchronisation may reduce all-cause mortality ...

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test, is hopelessly reliant on patient motivation. Hospital- All patients enrolled in the CONTAK CD trial [9,10], isation can also easily be biased by knowledge of treatment similar to the InSync ICD, had a clinical indication for ICD. allocation. 0167-5273/$ - see front matter D 2003 Elsevier Ireland Ltd.

Cardiac resynchronisation may reduce all-cause mortality ...

Septal to Posterior Wall Motion Delay Fails to Predict ...

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This study was designed to test the hypothesis that SPWMD would predict greater reverse remodeling and an improved clinical response in heart failure patients random-ized to CRT in the CONTAK-CD trial. METHODS Subjects. The VENTAK CHF/CONTAK-CD study en-rolled 581 patients from 47 investigational centers through-

Septal to Posterior Wall Motion Delay Fails to Predict ...

Cardiac resynchronization therapy in patients with right ...

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Request PDF on ResearchGate | Cardiac resynchronization therapy in patients with right bundle branch block: Analysis of pooled data from the MIRACLE and Contak CD Trials | Clinical trials of ...

Cardiac resynchronization therapy in patients with right ...

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) 1. GENERAL INFORMATION ... (Contak CD, Contak CD 2, Renewal, Renewal 3), was approved on October 21, 2003, and the indication stated above was further expanded to include: ... X. SUMMARY OF PRIMARY CLINICAL STUDY .

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

SYSTEM GUIDE COGNIS 100-D - usermanual.wiki

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SYSTEM GUIDE COGNIS™ 100-D CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR REF N118, N119 CAUTION: Federal law restricts this device to …

SYSTEM GUIDE COGNIS 100-D - usermanual.wiki

Effects of Cardiac Resynchronization on Disease ...

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Background— The effects of cardiac resynchronization therapy (CRT) in patients with mildly symptomatic heart failure have not been fully elucidated. Methods and Results— The Multicenter InSync ICD Randomized Clinical Evaluation II (MIRACLE ICD II) was a randomized, double-blind, parallel-controlled clinical trial of CRT in NYHA class II heart failure patients on optimal medical therapy ...

Effects of Cardiac Resynchronization on Disease ...

Safety and Effectiveness of Cardiac Resynchronization ...

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Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.

Safety and Effectiveness of Cardiac Resynchronization ...

M ACHTELIK | Researcher Profile | Symptoma.com

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M ACHTELIK published 5 Research Articles on Tachycardia, Ventricular Heart Failure Ventricular Dysfunction, Left Ventricular Dysfunction, Right Ventricular Fibrillation Check More at Symptoma.com

M ACHTELIK | Researcher Profile | Symptoma.com

CRT only or CRT plus ICD? | European Heart Journal ...

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The first patient enrolled in the study received the new CONTAK(TM) CD Congestive Heart Failure Device (CHFD)/EASYTRAK(TM) lead system, which provides pacing stimulation for both sides of the heart, along with cardioversion and defibrillation therapies.

CRT only or CRT plus ICD? | European Heart Journal ...

Guidant Announces First Implant of CONTAK CD/EASYTRAK ...

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Jill Schafer's 19 research works with 633 citations and 248 reads, including: Dyssynchrony, Left Ventricular Size, and Gender Predict Echocardiographic Response to Cardiac Resynchronization ...

Guidant Announces First Implant of CONTAK CD/EASYTRAK ...

Jill Schafer's research works | Boston Scientific, MA ...

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In contrast, in the CONTAK CD trial, there was no AV optimization whatsoever. 10 The SD determined AV optimization; a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) study was designed to compare these three alternative techniques and to assess the hypotheses that: (1) systematic AV delay optimization ...

Jill Schafer's research works | Boston Scientific, MA ...

SmartDelay Determined AV ... - PubMed Central (PMC)

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Cardiac Resynchronization Therapy in Patients with Mild Heart Failure: A Systematic Review and Meta-Analysis ... and its affiliated clinical trial registration data center, US Food and Drug Administration reports, Chinese Biomedical Literature Database CD-ROM, VIP Chinese Science and Technology Periodical Database, and China National

SmartDelay Determined AV ... - PubMed Central (PMC)

Cardiac Resynchronization Therapy in Patients with Mild ...

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The Contak CD trial enrolled class II patients, along with class III and IV subjects, into a single study protocol with a planned analysis that included all patients. NYHA class II patients who received CRT during the study showed a reduction in LV diameters but failed to demonstrate improve-ment in the composite outcome end point. The Contak CD

Cardiac Resynchronization Therapy in Patients with Mild ...

Effects of Cardiac Resynchronization on Disease ...

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original article The new england journal of medicine n engl j med 350;21 www.nejm.org may 20, 2004 2140 Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator

Effects of Cardiac Resynchronization on Disease ...

Cardiac-Resynchronization Therapy with or without an ...

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The VENTAK CHF/CONTAK-CD study en- subtracted from the QRS to posterior wall deflection value rolled 581 patients from 47 investigational centers through- to calculate the SPWMD (Fig. 1). Three measurements out the U.S. from February 1998 through December 2000. were made for each parameter and then averaged.

Cardiac-Resynchronization Therapy with or without an ...

Septal to Posterior Wall Motion Delay Fails to Predict ...

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Guidant Corp's bid to win premarket approval (PMA) for its Contak CD has been turned down by the FDA's Circulatory System Devices Panel. But the Indianapolis company vows it won't give up trying ...

Septal to Posterior Wall Motion Delay Fails to Predict ...

Guidant Corp loses PMA bid for Contak CD - Medscape

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M BOCCHIARDO published 5 Research Articles on Heart Failure Arrhythmias, Cardiac Tachycardia, Ventricular Ventricular Dysfunction, Left Ventricular Dysfunction, Right Check More at Symptoma.com

Guidant Corp loses PMA bid for Contak CD - Medscape

M BOCCHIARDO | Researcher Profile | Symptoma.com

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Cardiac Resynchronization Therapy for the Treatment of Heart Failure in Patients With Intraventricular Conduction Delay and Malig­nant Ventricular Tachyarrhythmias: VENTAK CHF/CONTAK CD Biventricular Pacing Trial: the objective of this study was to assess the safety and effectiveness of CRT in combination with an ICD in patients with HF class ...

M BOCCHIARDO | Researcher Profile | Symptoma.com
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