Heart FailureNCT02060110

MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE

An observational study of Heart Failure, run by Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Heart Failure
What is being tested?: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study and MADIT-CRT ICD ONLY ARM
Type of treatment: Medical device
How many people: 447 participants
Where: 1 siteIsrael
Study dates: May 2010to Jan 2014
How long will I take part?: 3 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The registry involves only those patients that participated in the MADIT-CRT IDE study within Europe.

Who may be able to join

Active patients who were enrolled in the MADIT-CRT IDE within Europe

Who cannot join

Patients who are unable or unwilling to comply with the protocol requirements

Trial locations and contacts

1 site in 1 country.

Israel1 site

Israeli Association for Cardiovascular Trials at Sheba Medical Center
Ramat Gan

Other trials in Israel

About this study

The registry is designed to determine the long-term mortality and morbidity benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE study.

Conditions: Heart Failure
Being tested: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study, MADIT-CRT ICD ONLY ARM
Keywords: CRT, HEART FAILURE
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the studyDevice
Also called Boston Scientific market approved cardiac resynchronization therapy defibrillators
MADIT-CRT ICD ONLY ARMDevice
Also called Market approved Boston Scientific implantable cardioverter defibrillators

Study groups in NCT02060110
Study group	Role	What they receive
MADIT-CRT CRT-D		Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study Receives: Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
MADIT-CRT ICD		Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study Receives: Device: MADIT-CRT ICD ONLY ARM

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause mortality
Measured: 36 month follow-up

Secondary outcomes (1)

Heart failure event or death
The combined end point of heart-failure or death, whichever came first.
Measured: 36 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jan 2014

First posted11 Feb 2014 (estimated)
Study startMay 2010
Primary completionSep 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Sheba Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 447 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060110
Sponsor's protocol ID: SHEBA-12-9492-IG-CTIL
Status last verified: Feb 2014
First submitted: 9 Feb 2014
Last updated: 11 Feb 2014
Results posted: No
Data monitoring committee: No

Publications

Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
PubMed 19723701
Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1.
PubMed 32605387
Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28.
PubMed 30592353
Sabbag A, Goldenberg I, Moss AJ, McNitt S, Glikson M, Biton Y, Jackson L, Polonsky B, Zareba W, Kutyifa V. Predictors and Risk of Ventricular Tachyarrhythmias or Death in Black and White Cardiac Patients: A MADIT-CRT Trial Substudy. JACC Clin Electrophysiol. 2016 Aug;2(4):448-455. doi: 10.1016/j.jacep.2016.03.003. Epub 2016 May 18.
PubMed 29759864
Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667.
PubMed 26823498
Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT-CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013.
PubMed 26124205
Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2.
PubMed 26038537
Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.
PubMed 24678999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE
ClinicalTrials.gov ID: NCT02060110
Acronym / sponsor ID: SHEBA-12-9492-IG-CTIL
Conditions: Heart Failure
Keywords: CRT, HEART FAILURE
Study type: Observational
Recruitment status: Completed
Enrolment: 447 participants (actual)
Lead sponsor: Sheba Medical CenterOther government
Collaborators: Israeli Association for Cardiovascular Trials - IACT
Study start: May 2010
Primary completion: Sep 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 11 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 2

Arm	Type	Receives
MADIT-CRT CRT-D	–	Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the studyPatients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
MADIT-CRT ICD	–	Device: MADIT-CRT ICD ONLY ARMPatients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The registry involves only those patients that participated in the MADIT-CRT IDE study within Europe.

Key inclusion criteria (1 listed)

Active patients who were enrolled in the MADIT-CRT IDE within Europe

Key exclusion criteria (1 listed)

Patients who are unable or unwilling to comply with the protocol requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the studyAlso: Boston Scientific market approved cardiac resynchronization therapy defibrillators	Device	MADIT-CRT CRT-D
MADIT-CRT ICD ONLY ARMAlso: Market approved Boston Scientific implantable cardioverter defibrillators	Device	MADIT-CRT ICD

Primary outcome

All-cause mortality
Time frame: 36 month follow-up

1 secondary outcome

Heart failure event or death
Time frame: 36 month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Background: PubMed 19723701Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
Derived from this study: PubMed 32605387Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1.
Derived from this study: PubMed 30592353Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28.
Derived from this study: PubMed 29759864Sabbag A, Goldenberg I, Moss AJ, McNitt S, Glikson M, Biton Y, Jackson L, Polonsky B, Zareba W, Kutyifa V. Predictors and Risk of Ventricular Tachyarrhythmias or Death in Black and White Cardiac Patients: A MADIT-CRT Trial Substudy. JACC Clin Electrophysiol. 2016 Aug;2(4):448-455. doi: 10.1016/j.jacep.2016.03.003. Epub 2016 May 18.
Derived from this study: PubMed 26823498Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667.
Derived from this study: PubMed 26124205Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT-CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013.
Derived from this study: PubMed 26038537Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2.
Derived from this study: PubMed 24678999Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 36 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060110, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.