Attain Success Clinical Trial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT00990964

First received: October 6, 2009

Last updated: August 13, 2012

Last verified: August 2012

History of Changes

Results First Received: August 13, 2012

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Heart Failure
Intervention:	Device: Attain Success Lead

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Attain Family Left Heart Lead	Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt

Participant Flow: Overall Study

	Attain Family Left Heart Lead
STARTED	2014 ^[1]
Attain Family Study System Attempt	1917 ^[2]
COMPLETED	1802 ^[3]
NOT COMPLETED	212

[1]	Total number of subjects enrolled
[2]	Total number of subjects with an Attain Family lead attempt after an Attain Family catheter attempt
[3]	Total number of subjects with successful Attain Family lead using Attain Family catheter

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Attain Family Lead	Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt

Baseline Measures

	Attain Family Lead
Number of Participants [units: participants]	2014
Age [units: participants]
<=18 years	0
Between 18 and 65 years	661
>=65 years	1353
Age [units: years] Mean ± Standard Deviation	69.1 ± 12.0
Gender [units: participants]
Female	576
Male	1438
Region of Enrollment [units: participants]
United States	1648
Taiwan	30
Hong Kong	7
Pakistan	11
Thailand	4
Malta	8
India	79
France	83
Canada	15
Puerto Rico	35
Malaysia	12
Poland	22
Singapore	3
Romania	5
Germany	6
China	46

Outcome Measures

Show All Outcome Measures

1. Primary:

Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter [ Time Frame: Implant ]

Show Outcome Measure 1

2. Primary:

Subjects Without a Left-heart Lead and Delivery Catheter Related Complication [ Time Frame: Implant to 3 months ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Attain Success Clinical Trial Leader
Organization: Medtronic, Inc.
phone: 800-328-2518 ext 62864
e-mail: medtronicCRMtrials@medtronic.com

No publications provided

Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00990964 History of Changes
Other Study ID Numbers:	Attain Success
Study First Received:	October 6, 2009
Results First Received:	August 13, 2012
Last Updated:	August 13, 2012
Health Authority:	United States: Institutional Review Board France: Conseil National de L'Ordre des Medecins India: Research Review Board Puerto Rico: Cardiovascular Center Taiwan: The Institutional Review Board of Taichung Veterans General Hospital Canada: The University of Western Ontario Office of Research

To Top