Clinical Trials Logo

Clinical Trial Summary

The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial alternative to conventional medical therapy in patients with a history of moderate heart failure. The investigators are looking to enroll approximately 180 people in this trial. Patients will be randomized in two groups. One group will be implanted with a pacemaker and will continue to receive conventional medical therapy as prescribed by their doctor. The second group will continue to receive conventional medical therapy as prescribed by their doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and external device testing will be collected both at the time of enrollment in the trial and during follow-up study visits. Patients who enter the study will be seen for study visits at 1 month, 3 and 6 months.


Clinical Trial Description

MADIT-ASIA is a multicenter, prospective, randomized clinical study. The primary aim is to show that two lead CRT-P with guideline-based optimal pharmacological therapy is associated with a significantly greater improvement in left ventricular ejection fraction (LVEF) at 6 months compared with guideline-based optimal pharmacologic therapy only.

The study will be initially conducted at approximately 25 centers in up to 9 countries in Asia including India, Thailand, Taiwan, Malaysia, China, Japan, South Korea and Singapore. If necessary, more sites may be invited to participate to meet the enrollment goal.

Following randomization, subjects will have scheduled clinic visit follow-ups at 1, 3 and 6-month intervals. Relevant event history, cardiac medications, physical assessment, device interrogation/programming status and adverse events will be collected at each follow-up visit. At the 6-month visit, a repeat echocardiogram and a 12-lead ECG will be obtained. Subjects will be followed through the 6 month visit. After that, subjects will have a safety follow up contact at the end of the study. The study will end when the last randomized subject reaches the 6 months visit. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01872234
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Terminated
Phase Phase 3
Start date February 2014
Completion date April 2014

See also
  Status Clinical Trial Phase
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Terminated NCT05594940 - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Completed NCT04394754 - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure N/A
Active, not recruiting NCT01385176 - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) N/A
Not yet recruiting NCT05516290 - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) Phase 4
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2